0% found this document useful (0 votes)
279 views47 pages

Taxanol PDF

Texanol is a colorless, liquid substance used primarily as a coalescing aid in latex paints. It has low toxicity. Occupational exposure is low due to manufacturing and processing occurring in closed, continuous equipment. Consumer exposure during latex paint application is also low, with average room concentrations below 1 ppm. Texanol does not persist in the environment and is not expected to bioaccumulate or pose a significant risk to human health or the environment based on its properties and expected exposure levels.

Uploaded by

sriatul2006
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
279 views47 pages

Taxanol PDF

Texanol is a colorless, liquid substance used primarily as a coalescing aid in latex paints. It has low toxicity. Occupational exposure is low due to manufacturing and processing occurring in closed, continuous equipment. Consumer exposure during latex paint application is also low, with average room concentrations below 1 ppm. Texanol does not persist in the environment and is not expected to bioaccumulate or pose a significant risk to human health or the environment based on its properties and expected exposure levels.

Uploaded by

sriatul2006
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 47

OECD SIDS TEXANOL

FOREWORD INTRODUCTION

TEXANOL
CAS N°: 25265-77-4

UNEP PUBLICATIONS
Identifiers, Physical and Chemical properties 73

Substance
End Point : IDENTIFIERS, PHYSICAL AND CHEMICAL PROPERTIES
Chemical Name : Propanoic acid, 2-methyl-, monoester with 2,2,4-trimethyl-1,3-
pentanediol
Common Name : Texanol
CAS Number : 25265-77-4

Synonyms
Chissocizer CS 12 CS 12
Isobutyraldehyde tishchenko trimer Isobutyric acid, ester with 2,2,4-trimethyl-1,3-
pentanediol
Texanol ester alcohol 2,2,4-Trimethyl-1,3-pentanediol monoisobutyrate

Properties & Definitions


Molecular Formula : C12H24O3
Molecular Weight : 216.32
Melting Point : -50C
Boiling Point : 244C
State : Liquid
Flash Point : 120C (o-cup)
Flamable Limit : 0.62% at 149C - 4.24% at 201C
Density : 0.95 at 20C
Vapour Pressure : 0.013 mbar (0.010 mmHg) at 20C
Octanol/Water Partition : log Pow = 3.47 at 25C experimental
Coefficient
Water Solubility : 858 mg/L at 18-22C *
Colour : Colourless
Odour : Mild
Additives : No additive typically present.
Impurities : 2,2,4-Trimethyl pentane-1,3-diol 0.1% (CAS RN: 144-19-4); TXBI
(texanol isobutyrate) 0.6% (CAS RN = 6846-50-0); NPGDI 0.1%; TMPI
: trace; 3-isobutyroxy-2,2,4-trimethyl pentanol: trace;
3-oxo-2,2,4-trimethyl penten-1-ol: trace; keto ester: trace.
General Comments : VP = 0.017 mbar (0.013 mmHg) at 25C is also reported.*In distilled water; 519
mg/L in diluent water at 18-22C. Vapor density : 7.45 (air=1); auto ignition
temperature 393C. Material is unlikely to accumulate a static charge which
could act as an ignition source. Stable; can react with strong oxidizing agents.
Polymerizaiton will not occur.

Overall Evaluation
EXPOSURE

ENVIRONMENTAL EXPOSURE

Based on its physiochemical properties, the test material will not be a persistent environmental contaminant.
With the exception of an unlikely spill situation (99% of the material is handled in closed tanks and drums;
formulation of latex paints, which accounts for 84% of the total use and over 97% use of the non-intermediate
use of the material is conducted in closed equipment), the only environmental exposure will be via the air during
the drying of paint. The low vapor pressure (0.013 mbar at 20C) and high boiling point (244C) of the material
would preclude high localized airborne concentrations of the test material. Estimated atmospheric residence
time for the test material is 403 hours, which predicts ultimate degradation of the test material in air.

CONSUMER EXPOSURE

The primary exposure to this substance is during its end use in latex paint, during application and subsequent
drying of the paint In order to characterize worker and consumer exposure to this material a study was
IRPTC Data Profile
74 Identifiers, Physical and Chemical properties
conducted in which airborne concentrations of the substance were measured in a study conducted to
characterize worker and consumer exposure to volatile components during field application and subsequent
drying of water based polyvinyl acetate paints. Paints were applied using airless spraying of roller/brush
methods in rooms having either 0.5 or 5.0 air changes per hour. For each scenario, a personal breathing zone
air sample was collected during application, and fixed station air samples were collected during application and
6 hours, 24 hours, and one week after application. The maximal concentration of the substance from breathing
zone samples was 0.99 ppm (during spraying applications) with a room air exchange rate of 5 air changes per
hour. At an exchange rate of 0.5 air changes per hour, the maximum concentration measured from fixed
stations during roller applications was 1.96 ppm. Overall average concentrations measured in rooms with an
exchange rate of 5.0 air changes per hour was only 0.44 ppm. The average concentration during spray
application in a room with 0.5 air changes per hour was 0.67 ppm, and the corresponding average for roller
applications was 0.37 ppm. Six hours after application, concentrations of the chemical were below the 0.33 ppm
average environmental limit of detection in the rooms with an air exchange rate of 5.0 air exchanges per hour.
At 24 hours, levels were below the limit level of detection of 0.19 ppm in 19 of 24 rooms (combined rooms
having either 0.5 or 5.0 air changes per hour). Only one of four samples collected at 7 days contained the
chemical at a concentration above the 0.01 ppm limit of detection.

OCCUPATIONAL EXPOSURE

In manufacture, dry, acid-free isobutyraldehyde is self-condensed in the presence of trace sodium isobutoxide
catalyst in an enclosed, continuous manufacturing system. The product mixture is water-washed to remove the
sodium salts, and then passes through distillation columns to remove the product from other substances also
formed from the chemical reaction. The refined product typically assay 99.0% or higher. The process water is
treated to remove essentially all remaining traces of product. The manufacturing process has various vents
which release insignificant amounts of the product because of its low volatility. There are two process waste
streams containing small amount of the product. These streams are incinerated.

During manufacture, fifteen one-liter samples are taken each day (347 days per year) for analysis. Thirty
minutes are required to take and analyze each sample. This operation is rotated among 40 different workers per
year. Some dermal exposure is possible (from spilling), but it would be slight and infrequent. During equipment
maintenance, the equipment is drained free of material. Mechanics wear protective goggles and impermeable
gloves; thus, dermal exposure is negligible. Some inhalation exposure may occur during drumming and loading
tank cars (15 minute operations), but inhalation exposure is not appreciable, since the substance has a low
vapor pressure and good ventilation is provided to the work area. Industrial hygiene monitoring of the work area
indicates that the 8-hour time-weighed average air concentration of the substance is typically less than 0.5 ppm.

During processing to make plasticizer, the substance is normally stored in tanks and transported through closed
lines to continuous reactors for chemical conversion. A small number of workers could be exposed for a few
minutes when taking small quality control samples prior to chemical conversion. The low vapor pressure of the
material minimizes the level of exposure during sampling.

Minimal exposure occurs routinely during handling of the material, since it is primarily (99%) stored in closed
tanks and in closed drums. Transport is predominantly in tank cars and tank trucks.

ASSESSMENT AND CONCLUSIONS

The potential occupational exposure is low because the substance is manufactured and processed in closed
continuous equipment. Inhalation exposure is further limited by the low vapor pressure of the substance. Dermal
exposure could occure infrequently by accident or during quality control sampling; however, it is the practice to
wear impermeable gloves and other protective clothing at points of potential exposure.

Consumer exposure is likely, since the predominant use of this substance is as a coalescing aid at up to 3%
concentration in latex paints. Although the number of consumers potentially exposed is high, the level of
exposure is low (average room concentration of 0.37 ppm during roller application of latex paint in a room with
0.5 room air changes per hour) during the few days per year the average consumer spends painting.

Environmental exposure occurs primarily through volatilization of the substance from drying latex paint.
Terrestrial and aquatic exposure would occur rarely through spills. The substance is predicted to undergo
photodecomposition slowly in the atmosphere, and does not persist elsewhere in the environment, because it
biodegrades at a modest rate.

The results of the SIDS testing indicate that the substance has a relatively low order of toxicity. Because of this
low level of toxicity, low level of human exposure, and lack of persistence in the environment, it is recommended
that a low priority be assigned to this substance for further testing.

IRPTC Data Profile


Production-Trade 75

Production-Trade
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Production
Quantity Year

44359 t - P 1989
25000-50000 t/y - P

General Comments : 25000 - 50000 tonnes/year (1977 TSCA Inventory).

References
!SIDSP*
OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


76 Processes

Processes
Chemical Name : Texanol
CAS Number : 25265-77-4

Process
Process comments : In manufacture, dry, acid-free isobutyraldehyde is self-condensed in the
presence of trace sodium isobutoxide catalyst in an enclosed, continuous
manufacturing system. The product mixture is water-washed to remove
the product from other substances also formed from the chemical
reaction. The refined product typically assays 99.0% or higher. The
process water is treated to remove essentially all remaining traces of
product. The manufacturing process has various vents which release
insignificant amounts of the product because of its volatility.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Uses 77

Uses
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Use
Quantity Year Comments

84 % Approximately 84% of the material is used as a


coalescing aid in latex paints where it is present at
about a 3% concentration.
14 % Approximately 14% of the material is used as a
chemical intermediate which is converted to other
chemical substances used as plasticizers.
2 % About 2% of the material may be used to make
dyestuffs, adhesives, building material agents,
detergents, cleaning agents, fertilizers, surface
treatment agents, or as a
solvent.

References

Secondary References : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


78 Pathways into the Environment and Environmental Fate

Study
End Point : Pathway into the Environment and Environmental Fate.
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Pathway and Transport


Pathway : INDST
Pathway description : Manufacturing

Quantity Transported
Medium to Medium Quantity Time Year to Year

to AIR 3-4 t/y


Estimated annual release during manufacture at Eastman Chemical Company, almost entirely to air.

to AIR 25 t/y
Release reported in the past, but is based on a calculation method used by the State of Texas that overstimates
fugitive emissions. Fugitive emissions will be determined again in 1993.
General Comments : Environmental release during customer processing is also estimated to be low
due to low vapour pressure and processing in closed equipment. Actual
environmental release data for customers who process the test material are
not available. Since 84% of this material is used as a coalescing aid for latex
paints, and is expected to evaporate during enduse, this atmospheric release
will be the major environmental release for this product. It is not expected that
this release will be concentrated in any particular geographic area or any
specific timeframe, and environmental concentrations in any locality are
expected to be negligible.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Concentration 79

Study
End Point : CONCENTRATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Subject
Organism Medium Specification Lifestage Sex

HUMAN AIR OCC ADULT

Test Method and Conditions


Test method : Estimation of exposure, National Paint and Coatings Association Study
description

Test Results
Matrix Concentrations Spec. Date

0.99 ppm
The maximal concentraion of this material from breathing zone samples (during applications) with a room air
exchange rate of 5 air changes per hour.

1.96 ppm
The maximum concentration measured from fixed stations during roller applications, at an exchange rate of 0.5
air changes per hour.

0.44 ppm
Overall average concentrations measured in rooms with an exchange rate of 5.0 air changes per hour.

0.67 ppm
The average concentration during spray application in a room with 0.5 air changes per hour.

0.37 ppm
The averge concentration during roller applications in a room with 0.5 air changes per hour.

<0.33 ppm
Six hours after application, test chemical concentrations were below the 0.33 ppm average environmental limit
of detection in the rooms with an air exchange rate of 5.0 air exchanges per hour.

<0.19 ppm
At 24 hours, levels were below the limit level of detection of 0.19 ppm in 19 of 24 rooms.

>0.01-0.01 ppm
Only one of four samples collected at 7 days contained the test amterial at a concentration above the 0.01 ppm
limit of detection.

General Comments : Airborne concentrations of texanol were measured in a study conducted to


characterize workers and consumer exposure to volatile components during
field application and subsequent drying of water based polyvinyl acetate
paints. Paints were applied using airless spraying or roller/brush methods in
rooms having either 0.5 or 5.0 air changes per hour. For each scenario, a
personal breathing zone air sample was collected during application, and
fixed station air samples were collected during application and 6 hours, 24
hours, and one week after application.

IRPTC Data Profile


80 Concentration

References
Primary Reference : ITCEV*
Kominsky, J. R. and Freyberg, R. W. International Technology
Corporation Exposure to Volatile Compounds of Polivinyl Acetate (PVA)
Emulsion Paints During Application and Drying : Report, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : CONCENTRATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification Lifestage Sex

HUMAN AIR OCC

Species/strain/system : Work area

Test Method and Conditions


Test method : Monitoring study
description

Test Results
Matrix Concentrations Spec. Date

AIR <0.5 ppm


Industrial hygiene monitoring of the work area indicates that the 8-hour time-weighed average air concentration
of the substance is typically less than 0.5 ppm.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Human Intake and Exposure 81

Study
End Point : HUMAN INTAKE AND EXPOSURE
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex

AIR OCC IHL ADULT

Test Method and Conditions


Test method : A quantitative potential inhalation dose may be derived using the
description equation (see comments) from a 1991 letter and an accompanying
document entitled "Screening Level Exposure Assessments" from E. F.
Bryan, USEPA to OECD Directorate.

Test Results

General Comments : PDR = Conc x IH x Dur x Freq, in which: PDR = Active inhalation potential
dose rate (mg/year); Conc = Average air concentration (mg/m3); IH =
Inhalation rate: 1.3 m3/hour, cited in above document; Dur = Duration of
exposure (hour/day) ; and Freq = Frequency of expsure (days/year). For a
commercial painter working 8 hours/day, 235 days/year, applying latex
paint containing 3% of the test chemical in a room with 0.5 air changes per
hour using the spray method (average concentration 0.67 ppm or 5.92
mg/m3), an annual worst-case dose may also be calculated.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : HUMAN INTAKE AND EXPOSURE
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex

AIR OCC IHL ADULT

IRPTC Data Profile


82 Human Intake and Exposure

Test Results

General Comments : During processing to make plasticizer, the substance is normally stored in
tanks and transported through closed lines to continuous reactors for
chemical conversion. A small number of workers could be exposed for a
few minutes when taking small quality control samples prior to chemical
conversion. The low vapour pressure of the material minimizes the level of
exposure during sampling. Minimal exposure occurs during handling of the
material, since it is primarily (99 %) stored in closed tanks and in closed
drums. Transport is predominantly in tank cars and tank trunks. The
primary exposure to this substance is during its end use in latex paint,
during application and subsequent drying of the paint. It is recommended
that exposure assessment for this chemical be centered on this exposure
point.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : HUMAN INTAKE AND EXPOSURE
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex

- SKN ADULT
AIR IHL

Test Results

General Comments : During manufacture, fifteen one-liter samples are taken each day (347 days
per year) for analysis. Thirty minutes are required to take and analyze each
sample. This operation is rotated among 40 different workers per year.
Some dermal exposure is possible (from spilling), but it would be slight and
infrequent. During equipment maintenance, the equipment is drained free of
material. Mechanics wear protective goggles and impermeable gloves; thus,
dermal exposure is negligible. Some inhalation exposure may occur during
drumming and loading tank cars (15 minutes operations) , but inhalation
exposure is not appreciable, since the substance has a low vapour pressure
and good ventilation is provided to the work area.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Biodegradation 83

Study
End Point : BIODEGRADATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification

AQ SLUDG

Species/strain/system : Sludge from secondary effluent derived from a commercial waste


treatment plant.

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : OECD Guideline 301 E (EEC/Annex V, Test C.3); GLP: yes
description

(An)aerobic : AEROB

Test Results
Quantity Time Comments on result

10 % 9d Degradation on day 9

33 % 19 d Degradation (by extrapolation) on day 19

70 % 34 d Degradation on day 34

90 % 42 d Degradation on day 42, when the test was terminated

General Comments : The data indicate that 33% of the material degrades in the 10-day time
window in which 70% degradation must occur in order for the chemical
to be classified as readily biodegradable. 70% biodegradation did not
occur until day 34. The results of this test indicate, however, that the test
material is unlikely to persist in the environment, but may not be fully
removed during wastewater treatment.

References
Primary Reference : #URKOD*
Waston, H. M. Eastman Kodak Company Reports, ES-91-020, (1991)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


84 Biodegradation

Study
End Point : BIODEGRADATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification

MCR AQ SLUDG

Species/strain/system : Acclimated sludge; secondary aeration basins of the Eastman Kodak


Company Waste Water Treatment Plant in Rochester, New York.

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environment Laboratories
description Protocol; GLP: yes

(An)aerobic : AEROB

Exposure
Exposure Period : 21 d
Exposure comments : A 21-day biodegradation test was conducted utilizing two sources of
acclimated sludge microorganisms. Acclimated organisms were used as
the source of inoculum for biodegradation testing. (See general
comments).

Test Results
Quantity Time Comments on result

57 % 11 d The extent of degradation of the test material, measured by carbon


dioxide evolution, using microorganisms acclimated for 11 days in a
single acclimation flask without the transfer of microorganisms.

19 % The extent of degradation using the transfer flask procedure

General Comments : In one procedure, microorganisms were acclimated over a 21-day period
by making a series of adaptive transfers to increasing concentrations of
the test chemical through a series of nine acclimation flasks. In the
second procedure, microorganisms were acclimated for 11 days in a
single acclimation flask without transfer of organisms. Based on the
results of this test, the material is classified as moderately
biodegradable. All material would utimately be biodegraded.

IRPTC Data Profile


Biodegradation 85

References
Primary Reference : #URKOD*
Waston, H. M. Eastman Kodak Company Reports, ES-85-011, (1986)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


86 Photodegradation

Study
End Point : PHOTODEGRADATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : FIELD
Medium : AIR
Geographic Area : USA

Test Results
Quantity Time Comments on result

50 % 400 h Approximate photodegradation half-life.

General Comments : The end use of approximately 84% of the substance is a coalescing
agent at up to 3% in latex paints. The substance enters the atmosphere
during application and drying of paint through evaporation, is dispersed
and undergoes photodegradation.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : PHOTODEGRADATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Medium : AIR
Geographic Area : USA

Test Method and Conditions


Test method : Estimation method: Handbook of Chemical Property Estimation Methods
description

Test Results

General Comments : Texanol does not absorb wavelengths of light above 290 nm and thus
will not be susceptible to direct (uncatalyzed) photodegradation. The
reaction of this material with hydroxide radical (OH.) will be the only
significant process by which this material would be removed from the
atmospheric environment. The following estimate can be made for the
atmospheric residence time: T(OH.) = 1 / K(OH.)(OH.) K(OH.) = 2.3E+12
cm3.mole-1.sec-1 (value for 2,2,4-trimethylpentane) and (OH.) = 3E-19
mole.cm3 (conservative value for Northern Hemisphere) Thus, T(OH.) =
1 / (2.3E+12)(3E-19) seconds or 403 hours.

IRPTC Data Profile


Photodegradation 87

References
Primary Reference : HBCPM*
Lyman, W. J. et al. Handbook of Chemical Property Estimation Methods,
Chapter 10, (1982)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


88 Hydrolysis

Study
End Point : HYDROLYSIS
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Medium : AQ
Geographic Area : USA

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : OECD Guideline 111 (EEC/Annex. V, Test C.10); GLP: yes. Data
description obtained from the tests, were analyzed using Arrhenius relationship to
calculate rate constants and half-lives.
Temperature : 25 c
pH : 9

Exposure
Dose / Concentration : The hydrolysis of both isomers was determined. Based on the results of
the preliminary test, further testing was conducted at pH 9. The data
from tests conducted at 50C, pH 9 provided hydrolysis profiles which
(see general comments).

Test Results
Quantity Time Comments on result

50 % 396 h Calculated half-life for one of the isomers at 25C and pH 9

50 % 103 h Calculated half-life for the second isomer at 25C and pH 9

General Comments : Closely resembled first-order kinetics.

References
Primary Reference : #URKOD*
Roser, K. S. Eastman Kodak Company Reports, 3VC3P43, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Bioconcentration 89

Study
End Point : BIOCONCENTRATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Results

General Comments : Bioaccumulation data is not required because the substance


biodegrades moderately rapid.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


90 Mammalian Acute Toxicity

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Sprague-Dawley rats


Frequency : 1x
Dose / Concentration : 3200 mg/kg BW

Test Method and Conditions


Test method : Eastman Kodak Company Health and Environment Laboratories Protocol
description similar to OECD Guideline 401; GLP: yes. Purity: 99%

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

RAT ORL M LD50 Oral LD50 for rats was refered as >3200
F mg/kg body weight.
General Comments : Fasted animals (4/dose) were administered the neat material by gavage at
doses of 1600 mg/kg and 3200 mg/kg. Slight transient weakness between one
and four hours after dosing with 3200 mg/kg was the only clinical abnormality
observed. There was no mortality. Prior studies in which limited numbers of
rats were administered the test chemical either neat on as a 10% solution in
corn oil yielded approximate LD50 values of 3200-6400 or 1600-3200 mg/kg.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Carworth-Wistar rats


Frequency : 1x
Dose / Concentration : 6.86 mg/kg BW

Test Method and Conditions


Test method : Mellon Institute Protocol; GLP: no (Test predates GLP).
description

IRPTC Data Profile


Mammalian Acute Toxicity 91

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

RAT ORL LD50 The single oral LD50 for rats was
determined to be 6.86 mL/kg (6517
mg/kg). The 95% confidence interval
was 4.64 - 10.1 mL/kg (4410 - 9595
mg/kg).

References
Primary Reference : TXAPA9
Carpenter, C. P. et al. Toxicology and Applied Pharmacology, 28, 313-319,
(1974)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Strain not identified


Frequency : 1x
Dose / Concentration : 1600-3200 mg/kg BW

Test Method and Conditions


Test method : Eastman Kodak Company Laboratory of Industrial Medicine Protocol; GLP: no
description (Test predates GLP).

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

MOUSE ORL M LD50 Oral LD50 for male mice was


determined as 1600 - 3200 mg/kg.
General Comments : The test was administered in corn oil to male mice (2/dose) at doses from 200
to 3200 mg/kg. Abnormal clinical signs observed were: weakness, rough
haircoat, prostration, vasodilatation and labored respiration, primary at the
highest dose. Both animals administered by the highest dose of 3200 died. All
other animals survived and gained weight.

References
Primary Reference : #URKOD*
Eastman Kodak Company Reports, (1960)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


92 Mammalian Acute Toxicity

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Strain not identified


Dose / Concentration : 3550 mg/m3 AIR

Test Method and Conditions


Test method : Animals were exposed for 6 hours to an atmosphere generated by passing air
description (3.5 L/minute) through the test material heated to 100C. Eastman Kodak
Company Laboratory of Industrial Medicine Protocol; GLP: no

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

RAT IHL LC50 Inhalation LC50 for rats was reported as


>= 3.55 mg/L/6 h (highest concentration
tested).
General Comments : Two groups of animals (3 rats/group) were exposed to nominal concentrations
of either 2.73 or 3.55 mg/L. There were no abnormal clinical signs or mortality
observed.

References
Primary Reference : #URKOD*
Eastman Kodak Company Reports, (1960)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Hartley guinea pigs


Exposure Period : 24 h
Dose / Concentration : 20 mL/kg BW

Test Method and Conditions


Test method : Eastman Kodak Company Health and Environment Laboratories Protocol;
description GLP: yes. The test chemical was applied at doses of 5 mL/kg (one animal), 10
mL/kg (one animal) or 20 mL/kg (three animals) to the depilated abdomens of
guinea pigs under an occlusive wrap for 24 hours. Animals were observed for
14 days following dosing.

IRPTC Data Profile


Mammalian Acute Toxicity 93

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

GPIG SKN LD50 Dermal LD50 for guinea pigs was


reported as >20 mL/kg (highest dose
tested).
General Comments : Administration of the test material at applied doses did not cause systemic
toxicity or death.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : New Zealand rabbits


Exposure Period : 24 h
Dose / Concentration : 16 mL/kg BW

Test Method and Conditions


Test method : The test chemical was applied to the skin under an impervious plastic film for
description 24 hours. Animals were observed for 14 days following dosing. Melon Institute
Protocol; GLP: no. (Test predates GLP).

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

RBT SKN LD50 Dermal LD50 for rabbits was reported


as >=16 mL/kg (15.2 g/kg).

References
Primary Reference : TXAPA9
Carpenter, C. P. et al. Toxicology and Applied Pharmacology, 28, 313-319,
(1974)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


94 Mammalian Acute Toxicity

Study
End Point : MAMMALIAN ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Strain not identified


Dose / Concentration : 800-1600 mg/kg BW

Test Method and Conditions


Test method : Eastman Kodak Company Laboratory of Industrial Medicine Protocol; GLP: no
description (Test predates GLP).

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

RAT IPR LD50 The estimated intraperitoneal LD50 was


800-1600 mg/kg in rats administered
the neat material, and 1600-3200 mg/kg
in rats and mice administered the
material in corn oil.
General Comments : The neat test material was administered via intraperitoneal injection into
groups of rats (2/dose) at doses of 200 to 3200 mg/kg. Groups of 2 rats and 2
mice were also injected with doses of 200 to 3200 mg/kg of the test material
as a 10% suspension in corn oil, clinical signs observed included weakness,
rough hair coats, tremors, convulsions, prostration, loss of reflexes and
vasodilatation.

References
Primary Reference : #URKOD*
Eastman Kodak Company Reports, (1960)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Mammalian Toxicity 95

Study
End Point : MAMMALIAN TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RAT ORL M 12 12
F 12 12

Species/strain/system : Sprague-Dawley rats

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : The test was conducted according to the proposed OECD Guideline for a
description Combined Repeat Dose and Reproductive) Developmental Toxicity Screening
Test (Draft dated March 22, 1990); GLP: yes

Exposure
Exposure Period : 40-51 d
Dose / Concentration : 100-1000 mg/kg BW/d
Exposure comments : Groups of rats were administered the test article by gavage at dose levels of 0,
100, 300, or 1000 mg/kg/day. Males received 51 doses over 51 days. Females
received between 40 and 51 doses of the test article during premating (14
days), mating (up to 14 days), pregnancy (21-22 days), and early lactation (4
days) periods.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
No treatment-related mortality occurred in this study.

GIT EXOC
Clinical signs were restricted to sialorrhea observed in males from all three dose groups and females from the
mid- and high-dose groups after administration of the test chemical. The post-dose sialorrhea may have been
due to the taste of the test article.

BEHAV 4 d
A slight statistically significant decrease in feed consumption was noted in both male and female high-dose
treatment groups at four days after the start of dosing.

NEF
No other feed consumption or body weight changes were noted.

IRPTC Data Profile


96 Mammalian Toxicity
KIDNY SIZE M
KIDNY STRUC
Statistically significantly heavier absolute and relative kidney weights were noted in the high-dose male rats and
histopathological changes included accumulation of hyaline droplets in the mid- and high- dose males.

LIVER SIZE
Heavier absolute and relative liver weights were observed in the low-, mid-, and high-dose male and female
groups.

LIVER CELL
Microscopic changes in the liver were noted in the mid- and high-dose groups and consisted of enlargement of
hepatocytes surrounding the central vein (centrilobular hepatocytomegaly ). The enlarged hepatocytes
contained cytoplasm characterised by an eosinophilic "ground glass" appearance.

The liver changes were minor in all cases and associated with increased metabolic activity resulting from test
article administration.
General Comments : The changes in the liver in the present study were considered to be associated
with metabolic activation, rather than to a toxicological effect. Because the
effects seen in the study were considered to be sequelae of metabolic
activation (liver effects) or unique to male rats (kidney effects), the testing
laboratory set the NOAEL for subchronic toxicity at 1000 mg/kg.

References
Primary Reference : #URKOD*
Faber, W. D. and Hosenfeld, R. S. Eastman Kodak Company Reports, TX-92-
57, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : MAMMALIAN TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RAT ORL M 5/GROUP 5


F 5/GROUP 5

Species/strain/system : Sprague-Dawley rats

Test Substance
Purity Grade : 99%
Vehicle - Solvent : Distilled water

Test Method and Conditions


Test method : Eastman Kodak Company Health and Environment Laboratories Protocol,
description similar to OECD Guideline 407; GLP: yes. Parameters evaluated included
clinical observations, body weights, feed consumption, hematology, clinical
chemistry, and gross and histopathology examinations.

IRPTC Data Profile


Mammalian Toxicity 97

Exposure
Exposure Type : SHORT
Exposure Period : 15 d
Dose / Concentration : 100-1000 mg/kg BW/d
Exposure comments : Groups of rats were administered the test material at doses of 0, 100, or 1000
mg/kg/day for 11 treatments over a period of 15 days.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
- BEHAV RV M
BW DECR
Tansient initial reductions in feed consumption and weight gain were observed in male rats at the 1000 mg/kg
dose level.

GIT EXOC RV
Clinical abnormalities were restricted to transient sialorrhea after administration of the test chemical.

NEF
There were no biologically significant differences between groups in red blood cells, hematocrit, white blood cell
count, and differential white blood cell count. There were a slightly lower hemoglobin concentration in the 100
mg/kg males, and a slightly lower platelet count in the

100 mg/kg females, but these differences were not dose related and were considered unrelated to the test
chemical.

NEF
Clinical chemistries (alanine amino transferase, aspartate aminotransferase, sorbitol dehydrogenase, alkaline
phosphatase, creatinine, urea nitrogen, and glucose) were not affected by exposure to the test chemical.

LIVER SIZE
Slight increases in absolute and relative liver weights were noted in both males and females from the 1000
mg/kg group.

NEF
Absolute and relative renal weights were comparable to controls.

KIDNY STRUC M
Histopathologic examination revealed mild changes (hyaline droplet formation, a frequently observed sex- and
species- specific phenomenon) in kidneys from males at both the 100 and 1000 mg/kg dose levels.
General Comments : Based on slightly increased liver weights in females at the 1000 mg/kg dose
level, the no-effect dose for the female rat was 100 mg/kg. Under the
conditions of this study, a no-effect dose was not obtained for males. Liver
weights were increased and hyaline droplets (a sex- and species-specific
effect) were seen in the kidneys in the 1000 mg/kg males, hyaline droplets
were also seen in the 100 mg/kg males.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


98 Mutagenicity

Study
End Point : MUTAGENICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

BACT VTR

Species/strain/system : Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 and


TA 100

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Salmonella typhimurium assay (Ames test); GLP: yes
description
Exposure
Dose / Concentration : 10-3164 mg/ PLATE
Exposure comments : The test material was tested with and without metabolic activation.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
Negative results. No increase in revertants was noted for concentrations between 10 mg/plate and 3164
mg/plate.

CELL
Minimum concentration at wich toxicity to bacteria was observed: 3164 mg/plate with and without metabolic
activation.

References
Primary Reference : #URKOD*
Eastman Kodak Company Reports, TX-85-5, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Mutagenicity 99

Study
End Point : MUTAGENICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

MOUSE

Species/strain/system : Swiss CD-1 mice

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Micronucleus Test; OECD Guideline 474 (limit dose of 2000 mg/kg); GLP: yes
description
Exposure
Dose / Concentration : 200-2000 mg/kg BW
Exposure comments : Groups of animals were dosed with 0, 200, 1000, or 2000 mg/kg of test
chemical.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
No significant increase in micronuclei in bone marrow polychromatic erthrocytes was seen under the conditions
of this assay in any dose group at any harvested time.

NEF
No effect on Mitotic Index or P/N Ratio was seen at any dose level.

2000 mg/kg produced transient acute toxicity in female mice.


General Comments : Under the conditions employed, the test article is negative in the in vivo
mammalian bone marrow micronucleus assay.

References
Primary Reference : #URKOD*
Barber, E. D. et al. Eastman Kodak Company Reports, TX-91-309, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


100 Sensitization

Study
End Point : SENSITIZATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

SKN

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : OECD Guideline 406 (Annex) (dated 12 May, 1981). GLP: yes
description
Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
Negative result for sensitization. Number of animals with skin reaction at challenge: 0. Number of animals with
skin reaction in control group at challenge: 0.
General Comments : An earlier study using a standardized topical method of induction was negative
for sensitization (see Eastman Kodak Company, Laboratory of Industrial
Medicine Toxicity Report, Dated February 12, 1984).

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Irritation 101

Study
End Point : IRRITATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

GPIG SKN

Species/strain/system : Hartley guinea pigs

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environment Laboratories Protocol;
description GLP: yes

Exposure
Exposure Type : ACUTE
Exposure Period : 24 h
Dose / Concentration : 5-20 mL/kg BW
Exposure comments : Animals were administered a dose of 20 mL/kg (three animals), 10 mL/kg (one
animal) or 5 mL/kg (one animal) to the depilated abdomen under an occlusive
wrap for 24 hours.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
SKIN IRRIT
Minimal irritation (slight to moderate erythema) was observed. Using the Draize method of evaluation, the
maximum score in a single animals at 24 hours was 2. The average score at 24 hour was 0.7. The maximum
score at 48 hours was 1. The average score at 48 hours was 0.3.
General Comments : The material was classified as a slight skin irritant.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


102 Irritation

Study
End Point : IRRITATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

GPIG SKN

Species/strain/system : Hartley guinea pigs

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environment Laboratories Protocol;
description GLP: yes

Exposure
Exposure Type : SHORT
Exposure Period : 9d
Dose / Concentration : 0.5 mL/ ANIMAL
Exposure comments : A group of 5 animals were repeatedly administered 0.5 mL of the test chemical
topically to the clipped skin of the back for a total of nine doses over an eleven-
day period. Both primary irritation and exacerbation of effects were measured.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
- NEF
SKIN IRRIT
No irritation or exacerbation was observed at the site of application in any of the 5 treated guinea pigs during
the first week of dosing. During the second week, slight, transient irritation was observed in three of five
animals.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Irritation 103

Study
End Point : IRRITATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RBT SKN

Species/strain/system : New Zealand rabbits

Test Method and Conditions


Test method : Mellon Institute Protocol; GLP: no. (Test predates GLP).
description
Exposure
Exposure comments : The test material was placed on the clipped skin of 5 rabbits. Evaluation of
irritancy was based on the severest reaction observed in the 24 hours following
application.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
SKIN IRRIT
Application of the test material resulted in an irritation score of 3 using the grading procedure used in the
Federal Hazardous Substances Act method, 21CFR, Past 191.

References
Primary Reference : TXAPA9
Carpenter, C. P. et al. Toxicology and Applied Pharmacology, 28, 313-319,
(1974)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : IRRITATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RBT OCU 6

Species/strain/system : New Zealand rabbits

IRPTC Data Profile


104 Irritation

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environment Laboratories Protocol,
description similar to OECD Guideline 405; GLP: yes

Exposure
Exposure Type : ACUTE
Exposure comments : The material was instilled into six rabbit eyes. Three eyes were washed
immediately.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
EYE IRRIT RV
Based on moderate (grade 2) erythema of the conjunctiva, the maximum score in a single unwashed eye was 4
(of a possible score of 110) after 24 hours.

EYE NEF
No signs of irritation were seen in washed eyes at any time. At 48 hours, the score for all eyes was 0.
General Comments : Based on the effects observed in unwashed eyes, the material was classified
as a slight to moderate eye irritant.

References
Primary Reference : #URKOD*
O'Donoghue, J. L. Eastman Kodak Company Reports, TX-84-35, (1984)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : IRRITATION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RBT OCU

Species/strain/system : New Zealand rabbits

Test Method and Conditions


Test method : Mellon Institute Protocol; GLP: no. (Test predates GLP).
description

IRPTC Data Profile


Irritation 105

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
EYE IRRIT
A grade of 4 was obtained using the evaluation procedure outlined in the Federal Hazardous Substances Act,
21CFR, Part 191.

References
Primary Reference : TXAPA9
Carpenter, C. P. et al. Toxicology and Applied Pharmacology, 28, 313-319,
(1974)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


106 Reproduction

Study
End Point : REPRODUCTION
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RAT ORL M 12/GROUP 12


F 12/GROUP 12

Species/strain/system : Sprague-Dawley rats

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Test was conducted according to the proposed OECD Guideline for a
description Combined Repeat Dose and Reproductive/Developmental Toxicity Screening
Test. GLP: yes. Parameters evaluated included clinical observations, body
weights, feed consumption, reproductive indices, postnatal pup observations,
and gross and histopathology examinations.

Exposure
Exposure Period : 40-51 d
Dose / Concentration : 100-1000 mg/kg BW/d
Exposure comments : Groups of rats were administered the test article by gavage at doses of 0, 100,
300 or 1000 mg/kg/day. Females received between 40 and 51 doses during
premating (14 days), mating (up to 14 days), pregnancy (21-22 days), and
easy lactation (14 days) periods. All males received 51 doses over 51 days.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
There were no toxicologically significant differences between the control and treated groups with respect to
reproduction and development in male and/or female rats. Evidence for copulation was noted for a all animals.

NEF
There were no differences in the number of pregnancies, number of live or dead pups, total number of implants,
prenatal loss, percent survival, total litter weight, mean pup weight, pup survival, or postnatal growth.
General Comments : Administration of the test article did not affect reproductive performance.
NOEL for reproductive toxicity was 1000 mg/kg.

References
Primary Reference : #URKOD*
Faber, W. D. and Hosenfeld, R. S. Eastman Kodak Company Reports, TX-92-
57, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Teratogenicity 107

Study
End Point : TERATOGENICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

RAT ORL M 12/DOSE 12


F 12/DOSE 12

Species/strain/system : Sprague-Dawley rats

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Test was conducted according to the proposed OECD Guideline for a
description Combined Repeat Dose and Reproductive/Developmental Toxicity Screening
Test (Draft Dated March 22, 1990); GLP: yes

Exposure
Exposure Type : SHORT
Exposure Period : 40-51 d
Dose / Concentration : 100-1000 mk/kg BW/d
Exposure comments : Groups of rats were administered the test article by gavage at dose levels of 0,
100, 300, or 1000 mg/kg/day. Female rats received between 40 and 51 doses
during premating (14 days), mating (up to 14 days), pregnancy (21-22 days,
and early lactation (4 days) period. Males received 51 doses over 51 days.

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NEF
Administration of the test article did not affect reproductive performance in terms of mean number of live or
dead pups/litter, total implants, prenatal loss, percent survival, total litter weight, mean pup weight, pup survival
, external defects, and postnatal growth.

Although two dams in the high-dose group had small litters, and one pregnant dam had a full term pregnancy
but no pups were found, the remaining seven litters in the high dose group averaged more pups per litter than
the control group. When the litter size data were ranked and analyzed, the high

-dose group of dams were also shown to have a statistically greater number of pups than the control.
General Comments : Within the design parameters of the protocol for this test, there were no
toxicologically significant differences between the control and treated groups
with respect to reproduction and development. The NOEL for developmental
toxicity was 1000 mg/kg.

IRPTC Data Profile


108 Teratogenicity

References
Primary Reference : #URKOD*
Faber, N. D. and Hosenfeld, R. S. Eastman Kodak Company Reports, TX-92-
57, (1992)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Aquatic Acute Toxicity 109

Study
End Point : AQUATIC ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Five species were tested; Ramshorn snail; Aquatic earthworm;


Sideswimmer; Crustacea (Pillbug); Flatworm
Dose / Concentration : 9.5-95 mg/L

Test Substance
Description of the test : Purity: 99%; nominal concentration of 10 uL/L - 100 uL/L of texanol in diluent
substance water.

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environmental Laboratories Protocol;
description static; GLP: yes. Temperature, dissolved oxygen and pH were measured at 0,
24, 48, 72, and 96 hours. Observations of mortality were made at 6, 24, 48,
72, and 96 hours.

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

SNAIL AQ LC50 LC50 (96 hours) for ramshorn snail;


WORM sideswimmer, and pillbug >= 95 mg/L
(100 uL/L).
CRUS
General Comments : Number exposed: 10/dose level, control: 10. Exposure of the five species was
simultaneous with two other species (daphnia and fathead minnows) in 20 L of
the test solution in a 23 L cuboidal container. All species except the snails
were maintained in separate wire mesh baskets. The daphnia were also
maintained in a separate mesh wire basket, and fathead minnows were
maintained directly in the tank.

References
Primary Reference : #URKOD*
Ziegler, D. A. Eastman Kodak Company Reports, ES-84-109, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : AQUATIC ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Water flea (Daphnia magna)


Dose / Concentration : 9.5-95 mg/L

Test Substance
Purity Grade : 99%
IRPTC Data Profile
110 Aquatic Acute Toxicity

Test Method and Conditions


Test method : Eastman Kodak Company, Health & Environmental Laboratories Protocol:
description GLP: yes. Daphnia (10/dose) were exposed to nominal concs. of texanol in
diluent water. Control = 10 in diluent water without the test chemical (see
general comments).

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

CRUS AQ FRESH LC50 LC50 >= 95 mg/L (100 uL/L).


General Comments : Exposure was simultaneous with six other species in 20 L of test solution in a
23 L cuboidal container. Daphnia were maintained in a wire mesh basket to
separate them from the other species. Other species (pillbig, sideswimmer,
flatworm, and aquatic earthworm) were also maintained is separate mesh wire
baskets. Fathead minnows and ramshorn snails were maintained directly in
the tank. Temperature, dissolved oxygen, and pH were measured at O, 24, 48,
72, and 96 hours. Observations of mortality were made at 6, 24, 48, 72 and 96
hours.

References
Primary Reference : #URKOD*
Ziegler, D. A. Eastman Kodak Company Reports, ES-84-109, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : AQUATIC ACUTE TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4

Species/strain/system : Fathead minnow (Pimephales promelas)


Dose / Concentration : 9.5-95 mg/L

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health & Environmental Laboratories Protocol;
description static; GLP: yes. The fish (10/dose) were exposed to nominal concs. of either
95 mg/L (100 uL/L) or 9.5 mg/L (10 uL/L) in diluent water (see general
comments).

IRPTC Data Profile


Aquatic Acute Toxicity 111

Test Results
Organism Medium Spec. Route Lifestage Sex Effect Effect Comments

FISH AQ FRESH LC50 LC50 = 30 mg/L (32 uL/L). The LC50


was calculated by non-linear
interpolation.
General Comments : Ten individuals were also maintained in diluent water without the test chemical
to serve as a control. Exposure was simultaneous with six other species in 20L
of test solution in a 23 L cuboidal container. Other species (pillbug,
sideswimmer, flatworm, aquatic earthworm, and daphnia) were maintained in
separate mesh wire baskets. The minnows, together with ramshorn snails,
were maintained directly in the tank. Temperature, dissolved oxygen, and pH
were measured at 0, 24, 48, 72, and 96 hours. Observations of mortality were
made at 6, 24, 48, 72, and 96 hours.

References
Primary Reference : #URKOD*
Ziegler, D. A. Eastman Kodak Company Reports, ES-84-109, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


112 Aquatic Toxicity

Study
End Point : AQUATIC TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Evaluations
Evaluation text : Long-term tests e.g., reproduction: no data available. Chronic daphnia, pillbug,
sideswimmer, flatworm, aquatic worm, or snail studies are not deemed
necessary because substance shows low acute toxicity to these organisms.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Aquatic Toxicity 113

Study
End Point : AQUATIC TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

ALGAE AQ FRESH

Species/strain/system : Algae (Selenastrum capricornutum)

Test Substance
Purity Grade : 99%

Test Method and Conditions


Test method : OECD Guideline 201; GLP: yes
description
Exposure
Exposure Period : 72 h
Dose / Concentration : 2.5-80 mg/L
Exposure comments : The test organism was exposed over a 72-hour period to six concs. (2.5-80
mg/L, nominal; 1.1 to 57 mg/L, measured) of texanol. Percent inhibition
relative to control at 24, 48 and 72 hours was calculated for each (see general
commnets).

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
EC50
The 72-hour EC value, based on analytically measured amounts of material, was 18.4 mg/L.

NOEC
NOEC (no observed effect concentration) at 72 hours was 3.28 g/L.

NEL
Maximum concentration at which no effect was observed within the period of the test = 3.28 mg/L.

LOEC
Minimum concentration at which effect was observed within the period of the test = 7.28 mg/L.
General Comments : concentration based upon the area under the growth curves. The test material
is rated "moderately toxic" to the test species. However, since the test
substance is ultimately biodegradable, if it were to reach the environment,
adverse effects on algal growth are anticipated to be minimal.

IRPTC Data Profile


114 Aquatic Toxicity

References
Primary Reference : MALPI*
Hughes, J. S. and Alexander, M. M. Malcom Pirnie. The toxicity of HAEL No
91-0053 to Selenastrum Capricornutum

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

Study
End Point : AQUATIC TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

MCR AQ

Species/strain/system : Bacteria; activated sludge

Test Substance
Description of the test : Purity: 99%
substance

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environmental Laboratories Protocol;
description IC50; Secondary Waste Treatment; GLP: yes
Temperature : 27 C
pH : 6.9

Exposure
Exposure Period : 5h
Dose / Concentration : 0.215-215 mg/L
Exposure comments : This test utilized secondary waste treatment micro-organisms which are
characteristic of actual treatment plant sludge, and which were cultured in a
continuous-flow laboratory sludge unit. (see general comments).

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
EC50
EC50 for inhibition >= 215 mg/L

NOAEL
Exposure to 21.5 mg/L, 2.15 mg/L, and 0.215 mg/L had no adverse effect on glucose metabolism.

IRPTC Data Profile


Aquatic Toxicity 115

General Comments : Test exposures were conducted in respirometer flasks containing the test
chemical, sludge, (14C) glucose, and 0.02 M phosphate buffer, pH 6.9. The
test article exposure flasks contained the test chemical at concentrations of
215 mg/L, 21.5 mg/L, 2.15 mg/L, or 0.215 mg/L. The negative control
exposure flasks contained K2Cr2O7 at 333, 167, 33, and 3.3 mg/L. All
exposures were performed simultaneously and in triplicate; with gentle shaking.

References
Primary Reference : #URKOD*
Ziegler, D. A. Eastman Kodak Company Reports, ES-84-109, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


116 Terrestrial Toxicity

Study
End Point : TERRESTRIAL TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

BIRD

General Comments : No data available. This material is manufactured and used in such a way that
significant exposure of avian life to appreciable concentrations of this
substance is deemed remote.

References

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile


Terrestrial Toxicity 117

Study
End Point : TERRESTRIAL TOXICITY
Chemical Name : Texanol
CAS Number : 25265-77-4
Study type : LAB
Geographic Area : USA

Test Subject
Organism Medium Specification Route Lifestage Sex Number exposed Number controls

PLANT TERR 4x20/TYPE

Species/strain/system : Ryegrass (Lolium perene); Radish (Raphanus sativus); Lettuce


(Lactuca sativa)

Test Substance
Description of the test : 95 mg/L (100 uL/L)
substance
Purity Grade : 99%

Test Method and Conditions


Test method : Eastman Kodak Company, Health and Environment Laboratories Protocol;
description GLP: yes. End points: plant height, root length, and germination.

Exposure
Dose / Concentration : 95 mg/L
Exposure comments : Four replicates of twenty radish, lettuce, and ryegrass seeds were dispersed in
growth pouches (a total of 80 seeds for each type of plant). 20 mL of test
chemical at a nominal conc. of 95 mg/L (100 uL/L) was added to (see general
comments)

Test Results
Affected in
Organ Effect Rev. OnSet Sex Exposed - Controls
--------- ----------- ------- ------------------- ------- -----------------------------
NOEC
Maximum concentration at which no effect was observed within the period of the test: no effect was seen at 95
mg/L (100 uL/L) in any of the species tested (7 days).

LOEC
Minimum (lowest) concentration at which effect was observed within the period of the test: not observed. Plants
were exposed only to a concentration of 95 mg/L (100 uL/L).
General Comments : Each growth pouch, and pouches were placed in a light-tight chamber for
seven days at room temperature. Criteria for inhibition were values of less than
90% of the concurrent control group for any of the three end points.

References
Primary Reference : #URKOD*
Ziegler, D. A. Eastman Kodak Company Reports, ES-84-109, (1985)

Secondary Reference : !SIDSP*


OECD/SIDS. Screening Information Data Set (SIDS) of OECD High
Production Volume Chemicals Programme, (1994)

IRPTC Data Profile

You might also like