Industrial Use of Agidol-1
Industrial Use of Agidol-1
in accordance to Regulation (EC) No 1907/2006 (as amended by Commission Regulation (EU) No 453/2010)
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1.2. Relevant identified uses of the substance or mixture and uses advised against
Identified uses: BHT is a registered antioxidant, licensed for food and animal feed
products, cosmetics, packaging materials.
Because of its chemical-physical properties, BHT is used as an
antioxidant/stabiliser in a wide variety of products, including petroleum
products, synthetic rubbers, plastics, elasomers, oils, waxes, soaps,
paints, inks, etc.
BHT as such is used at industrial settings only. It is not available to
consumers as such.
BHT is present in the end-use products as a substance bound into or onto
matrix.
The CSR defines the following uses of BHT:
IU0 [importation and storage –INDUSTRIAL USE];
IU1 [Use as a stabilizing (antioxidant) component substance in
manufacture of other (any, not specified) products–
INDUSTRIAL USE]
IU2 [General Use as a stabilizing (antioxidant) component
substance within other (any, not specified) products –
INDUSTRIAL, PROFESSIONAL, CONSUMER USE ]
Uses advised against: BHT shall not be available to general public/consumers as such.
BHT shall not be used in contradiction to all relevant national/regional
restrictions applied to this substance, including, but not limited to, those
prescribed by REACH regulation.
Exposure scenario(s): For detailed information on exposure assessment, please, refer Annex I
to this eSDS.
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GHS09: environment
Hazard statements:
H410: Very toxic to aquatic life with long lasting effects.
Precautionary statements:
Prevention:
P273: Avoid release to the environment.
Response:
P391: Collect spillage.
Disposal:
P501: Dispose of contents/container in accordance with local/ regional/
national/ international regulation.
Labelling according to the Not applicable.
DSD/DPD criteria of Annex I of
Directive 67/548/EEC and as
reported in Regulation (EC) No
1272/2008 (Annex VI, table 3.2):
2.3. Other hazards
Physical Chemical Hazards: Fire and Explosion Hazards:
• Fire Potential: Slight.
• Hazardous Decomposition: When heated to decomposition,
this substance emits toxic fumes.
Chemical Hazard:
• The substance decomposes on burning and on contact with
oxidizing materials.
Human Health Hazards: Eye and Skin Contact:
• May cause skin and eye redness.
Inhalation:
• Respiratory irritation effects (i.e. cough, sore throat) may
occur on inhalation to dust particles of BHT.
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3.1. Substances
Main constituent(s): CAS No Chemical name % (mass) EC No
128-37-0 2,6-di-tert-butyl-p- ≥ 99% 204-881-4
cresol
Stabilizer(s): Not used
Other Hazardous Components/ Absent
Impurities:
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Unusual fire and explosion • When heated to decomposition, this substance emits toxic
hazards: fumes
5.3. Advice for firefighters
Special fire fighting procedures: • Avoid unnecessary run-off of fire-prevention media and of
extinguishing media (water cooling, fighting a fire with
water and foam) which may cause pollution at contact with
BHT.
Personal protection: • Use corresponding protective clothes, individual means of
eye protection, self contained breathing apparatus.
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PLANT AGIDOL-1 CAS No. 128-37-0 Date: 01/01/2011
Explosive properties: Not explosive, Contains no groups associated with explosive properties.
Oxidising properties: Not oxidizing
9.2. Other information
Henry’s law constant (HLC): BHT dissolves in etanol, acetone, ecetic ether, methylene chloride,
carbon tetrachloride, benzol, benzene, fats.
0.342 Pa-m3/ mole (estimated, at 25 ºC)
10.1. Reactivity
Chemical dangers: • The substance decomposes on burning and on contact with
oxidizing materials.
10.2. Chemical stability
Stability conditions: • Stable if stored and applied as directed
10.3. Possibility of hazardous reactions
Special precautions: • Store separated from strong oxidants.
10.4. Conditions to avoid
Conditions contributing to • Keep away from heat and sources of ignition
instability:
10.5. Incompatible materials
Incompatibilities: • The substance decomposes on burning and on contact with
oxidizing materials.
10.6. Hazardous decomposition products
Hazardous decomposition • When heated to decomposition, this substance emits toxic
products: fumes.
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PLANT AGIDOL-1 CAS No. 128-37-0 Date: 01/01/2011
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Respiratory sensitisation:
In accordance with the CLP criteria, respiratory sensitizer is defined as
“a substance that will lead to hypersensitivity of the airways following
inhalation of the substance”. Generally, a substance is classified as
respiratory sensitizer if there is evidence in humans that the substance
can lead to specific respiratory hypersensitivity and/or if there are
positive results from an appropriate animal test.
Currently, no recognized animal models for the testing of respiratory
hypersensitivity are available.
Therefore, evidence that a substance can induce specific respiratory
hypersensitivity will normally be based on human experience. However,
no hypersensitivity reactions associated with exposure to BHT were
reported in humans.
In conclusion, based on the respiratory sensitization data summarized
here and taking into account that there have been no reports of
respiratory sensitization caused by BHT, it is not considered to be a
respiratory sensitizer.
Germ cell mutagenicity: BHT showed no potential to cause point mutations in bacterial and
mammalian test systems (WHO, 1986; OECD, 2005).
Additionally, BHT was estimated for mutagenic properties with the
currently available QSAR/SAR model for this endpoint (CAESAR
QSAR model for Mutagenicity v.[Link]) with overall result: Non-
Mutagen.
There are no data on genotoxicity of BHT in humans.
Based on the data, summarised in this section, BHT is not considered as
being genotoxic/ mutagenic.
Carcinogenicity The NTP 2-year study of carcinogenicity of BHT in rats and mice
observed no treatment-related neoplastic lesions. The study authors
concluded that BHT was not carcinogenic for F344 rats or B6C3F1 mice
under applied test conditions (NTP, 1979).
The International Agency on Research of Cancer (IARC) provides the
following evaluation of carcinogenicity of BHT (IARC, 1986, 1987):
• Overall evaluation BHT: is not classified as carcinogen
(Group 3).
Overall, BHT is not considered to be carcinogenic.
Reproductive toxicity: In general, there is no clear evidence for a direct effect of BHT on
fertility/ fetal development, in the absence of systemic toxicity.
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12.1. Toxicity
Aquatic environment: BHT is not considered to degrade fast in the environment. The
BCF/BAF values estimated for BHT are above the cut-off values for
bioaccumulation (<500 L/kg wet-w) suggesting that BHT may have
some potential for bioaccumulation in aquatic life.
The ecotoxicity data on BHT are summarised as follows:
• Acute toxicity: LC50(EC50) <1 mg/L (published data and
estimated with ECOSAR v.1.00);
• Chronic toxicity: NOEC <1 mg/L (published data and
estimated with ECOSAR v.1.00).
This corresponds to Chronic Category 1 toxicity classification for BHT.
Acute toxicity: L(E)C50 0.464 mg/L fish, ECOSAR estimated
0.386 mg/L invertebrates, ECOSAR estimated
0.84 mg/L invertebrates, measured
0.577 mg/L green algae, ECOSAR estimated
Chronic toxicity: L(E)C50 0.096 mg/L invertebrates, measured
Terrestrial environment: There are no data on toxicity of BHT to terrestrial (soil) organisms.
BHT is a non volatile solid substance which is insoluble in water. The
value for soil organic carbon-water partition coefficient calculated using
KOCWIN v. 2.0 (log Koc = 3.91 -4.17) suggests that BHT has some
potential to adsorb onto soil and sediment.
In the absence of ecotoxicity data for soil organisms, the PNEC soil is
calculated using the equilibrium partitioning method (EPM) as follows
(in accordance with ECHA Guidance on Information Requirements, Part
B):
PNEC soil =(0.174 + 0.0104 x Koc) x PNEC water.
Estimated Koc for BHT =8183 -14750 L/kg (by following a
precautionary approach, the lowest estimated Koc value of 8183 L/kg
will be used in the calculation); PNEC water =0.004 mg/L.
Therefore, PNEC soil= 0.350 mg/kg is calculated for BHT.
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PLANT AGIDOL-1 CAS No. 128-37-0 Date: 01/01/2011
14.1. UN number
UN No: 3077
14.2. UN proper shipping name
UN Proper Shipping Name: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.
2,6-di-tert-butyl-p-cresol
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15.1. Safety, health and environmental regulations/legislation specific for the substance or
mixture
Export and Import of Dangerous This substance is not listed in the Annex I of Regulation (EC) No
Chemicals (Regulation (EC) No 689/2008.
689/2008) Information:
CLP Regulation (EC) No This substance is not listed in Annex VI (tables 3.1 and 3.2) to CLP
1272/2008: regulation.
REACH Regulation (EC) No This substance is registered in accordance with provisions of REACH
1907/2006: regulation. For registration number, please refer section 1.1 of this
eSDS.
15.2. Chemical safety assessment
CSA: Chemical Safety Assessment has been carried out for this chemical in
accordance with provisions of REACH regulation.
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Annex I
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Annex II
Info from the International Programme on Chemical Safety (IPCS) publicly available at
[Link] (data retrieved on 28 June 2010)
ICELAND Reykjavik
Iceland Poisons Information Centre
Emergency telephone: +354 525 111, Landspitali University Hospital
+354 543 2222 Fossvogi
Reykjavik 108
IRELAND (REPUBLIC OF) Dublin
National Poisons Information Centre
Emergency telephone: +353 1 Beaumont Hospital
8379964 P.O. BOX 1297
Beaumont Road
Dublin 9
ISRAEL Haifa
Israel Poisons Information Centre
Rambam Medical Centre
Emergency telephone: +972 4 854 PO Box 9602
1900 Haifa 31096
ITALY Rome Roma
Centro Antiveleni (Poisons Centre)
Dipartimento di Tossicologia Clinica
Emergency telephone: +39 06 305 Universita Cattolica del Sacro Cuore
4343 Largo Agostino Gemelli 8
I-00168 Roma
LATVIA Riga
Latvian Poisons Information Centre
Emergency telephone: +371 704 2468 Clinical Hospital "Gailezers"
2 Hipocrate Street
Riga LV 1038
LITHUANIA Vilnius
Poisons Control and Information Bureau
Emergency telephone: +370 2 36 20 Siltnamiu 29
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NETHERLANDS Bilthoven
this service is only available to health professionals
Emergency telephone: +31 30 274 88 National Poisons Information Centre
88 National Institute for Public Health and the Environment
P.O. Box 1
Bilthoven 3720 BA
NORWAY Oslo
Poisons Information
Emergency telephone: +47 22 591300 Directorate of Health and Social Affairs
P.O. Box 7000
St. Olavs Plass
0130 Oslo
POLAND Warsaw Warszawa
Warsaw Poison Control and Information Centre
Emergency telephone: +48 22 619 66 Praski Hospital
54; +48 22 619 08 97 Al. Solidarnosci 67
P-03 401 Warszawa
PORTUGAL Lisbon Lisboa
Centro de Informação Antivenenos – Dra Arlinda Borges
Emergency telephone: 808 250 143 Instituto Nacional de Emergência Médica (INEM)
(for use only in Portugal), +351 21 Rua Almirante Barroso, 36
330 3284 1000-013 Lisboa
ROMANIA Department of Clinical Toxicology
Spitalul de Urgenta Floreasca
Emergency telephone: +40 21 230 Calea Floreasca
8000 Bucharest
SLOVAKIA Bratislava
National Toxicological Information Centre
Emergency telephone: +421 2 54 77 4 University Hospital Bratislava
166 Limbová 5
833 05 Bratislava
SLOVENIA Ljubljana
Poison Centre
Emergency telephone: + 386 41 650 Division of Internal Medicine
500 University Clinical Centre Zaloska 7,
1525 Ljubljana
SPAIN Madrid
Servicio de Información Toxicológica
Instituto Nacional de Toxicología
Emergency telephone: +34 91 562 04 Departamento de Madrid
20 Calle Luis Cabrera 9
E-28002 Madrid
SWEDEN Stockholm
Giftinformationscentralen (Swedish Poisons Information Centre)
Karolinska Hospital
Emergency telephone: +46 8 33 12 31 SE-171 76 Stockholm
(International) 112 (National)
SWITZERLAND Zurich
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