Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
Issue date: 03/04/2023 Version: 1.0
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier
Product form : Substance
Substance name : Paracetamol impurity K
Chemical name : 4-aminophenol
EC Index-No. : 612-128-00-X
EC-No. : 204-616-2
CAS-No. : 123-30-8
Product code : 201601115
1.2. Relevant identified uses of the substance or mixture and uses advised against
1.2.1. Relevant identified uses
Main use category : The product is intended for research, analysis and scientific education.
Use of the substance/mixture : For professional use only
Function or use category : Laboratory chemicals
1.2.2. Uses advised against
Restrictions on use : Do not use : Ingestion, Inhalation, Dermal
1.3. Details of the supplier of the safety data sheet
European Directorate for the Quality of Medicines & Healthcare
EDQM, Council of Europe 7, Allée Kastner, CS30026
F– 67081 Strasbourg
France
T +33(0)388412035 - F +33(0)388412771
[email protected] - www.edqm.eu
1.4. Emergency telephone number
Emergency number : +33(0)390215608
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP]
Germ cell mutagenicity, Category 2 H341
Acute toxicity (inhal.), Category 4 H332
Acute toxicity (oral), Category 4 H302
Hazardous to the aquatic environment – Acute Hazard, Category 1 H400
Hazardous to the aquatic environment – Chronic Hazard, Category 1 H410
Full text of H- and EUH-statements: see section 16
Adverse physicochemical, human health and environmental effects
Expert judgement and weight of evidence determination.
2.2. Label elements
Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Hazard pictograms (CLP) :
GHS08 GHS07 GHS09
Signal word (CLP) : Warning
Hazard statements (CLP) : H341 - Suspected of causing genetic defects.
H332 - Harmful if inhaled.
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
H302 - Harmful if swallowed.
H410 - Very toxic to aquatic life with long lasting effects.
Precautionary statements (CLP) : P202 - Do not handle until all safety precautions have been read and understood.
P261 - Avoid breathing dust.
P308+P313 - IF exposed or concerned: Get medical advice/attention.
Labelling according to: exemption for inner packaging where the contents do not exceed 10ml
Hazard pictograms (CLP) :
GHS08
2.3. Other hazards
No additional information available
SECTION 3: Composition/information on ingredients
3.1. Substances
Name Product identifier % Classification according to
Regulation (EC) No. 1272/2008
[CLP]
4-aminophenol CAS-No.: 123-30-8 ≤ 100 Muta. 2, H341
EC-No.: 204-616-2 Acute Tox. 4 (Inhalation), H332 (ATE=1,5
EC Index-No.: 612-128-00-X mg/l/4h)
Acute Tox. 4 (Oral), H302 (ATE=500
mg/kg bodyweight)
Aquatic Acute 1, H400
Aquatic Chronic 1, H410
Full text of H- and EUH-statements: see section 16
3.2. Mixtures
Not applicable
SECTION 4: First aid measures
4.1. Description of first aid measures
First-aid measures after skin contact : Wipe off as much as possible (using a clean, soft, absorbent material).
First-aid measures after eye contact : Rinse eyes with water as a precaution.
4.2. Most important symptoms and effects, both acute and delayed
No additional information available
4.3. Indication of any immediate medical attention and special treatment needed
No additional information available
SECTION 5: Firefighting measures
5.1. Extinguishing media
Suitable extinguishing media : Extinguishing blanket.
5.2. Special hazards arising from the substance or mixture
Fire hazard : See Heading 2.2.
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
5.3. Advice for firefighters
Firefighting instructions : Use extinguishing media appropriate for surrounding fire.
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
6.1.1. For non-emergency personnel
Emergency procedures : Avoid all unnecessary exposure.
6.1.2. For emergency responders
No additional information available
6.2. Environmental precautions
No additional information available
6.3. Methods and material for containment and cleaning up
No additional information available
6.4. Reference to other sections
No additional information available
SECTION 7: Handling and storage
7.1. Precautions for safe handling
No additional information available
7.2. Conditions for safe storage, including any incompatibilities
No additional information available
7.3. Specific end use(s)
See Heading 1.
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
8.1.1 National occupational exposure and biological limit values
No additional information available
8.1.2. Recommended monitoring procedures
No additional information available
8.1.3. Air contaminants formed
No additional information available
8.1.4. DNEL and PNEC
No additional information available
8.1.5. Control banding
No additional information available
8.2. Exposure controls
8.2.1. Appropriate engineering controls
Appropriate engineering controls:
Keep in a well-ventilated room. Both local exhaust and general room ventilation are usually required.
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
8.2.2. Personal protection equipment
8.2.2.1. Eye and face protection
No additional information available
8.2.2.2. Skin protection
Skin and body protection:
Lab coat
Hand protection:
Protective gloves
8.2.2.3. Respiratory protection
No additional information available
8.2.2.4. Thermal hazards
No additional information available
8.2.3. Environmental exposure controls
No additional information available
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
Physical state : Solid
Colour : Not available
Appearance : Powder.
Odour : Not available
Odour threshold : Not available
Melting point : Not available
Freezing point : Not available
Boiling point : Not available
Flammability : Not available
Explosive limits : Not applicable
Lower explosion limit : Not applicable
Upper explosion limit : Not applicable
Flash point : Not applicable
Auto-ignition temperature : Not applicable
Decomposition temperature : Not available
pH : Not available
pH solution : Not available
Viscosity, kinematic : Not applicable
Solubility : Not available
Partition coefficient n-octanol/water (Log Kow) : Not available
Vapour pressure : Not available
Vapour pressure at 50°C : Not available
Density : Not available
Relative density : Not available
Relative vapour density at 20°C : Not applicable
Particle size : Not available
9.2. Other information
9.2.1. Information with regard to physical hazard classes
No additional information available
9.2.2. Other safety characteristics
No additional information available
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
SECTION 10: Stability and reactivity
10.1. Reactivity
Stable under normal conditions.
10.2. Chemical stability
No additional information available
10.3. Possibility of hazardous reactions
None known.
10.4. Conditions to avoid
No additional information available
10.5. Incompatible materials
None under normal use. See Section 7.
10.6. Hazardous decomposition products
When heated to decomposition, emits dangerous fumes.
SECTION 11: Toxicological information
11.1. Information on hazard classes as defined in Regulation (EC) No 1272/2008
Acute toxicity (oral) : Harmful if swallowed.
Acute toxicity (dermal) : Not classified
Acute toxicity (inhalation) : Harmful if inhaled.
Skin corrosion/irritation : Not classified
Serious eye damage/irritation : Not classified
Respiratory or skin sensitisation : Not classified
Germ cell mutagenicity : Suspected of causing genetic defects.
Carcinogenicity : Not classified
Reproductive toxicity : Not classified
STOT-single exposure : Not classified
STOT-repeated exposure : Not classified
Aspiration hazard : Not classified
11.2. Information on other hazards
No additional information available
SECTION 12: Ecological information
12.1. Toxicity
Ecology - general : Presents no specific risk for the environment.
Hazardous to the aquatic environment, short–term : Very toxic to aquatic life.
(acute)
Hazardous to the aquatic environment, long–term : Very toxic to aquatic life with long lasting effects.
(chronic)
12.2. Persistence and degradability
No additional information available
12.3. Bioaccumulative potential
No additional information available
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
12.4. Mobility in soil
No additional information available
12.5. Results of PBT and vPvB assessment
No additional information available
12.6. Endocrine disrupting properties
No additional information available
12.7. Other adverse effects
No additional information available
SECTION 13: Disposal considerations
13.1. Waste treatment methods
No additional information available
SECTION 14: Transport information
In accordance with ADR / IMDG / IATA
ADR IMDG IATA
14.1. UN number or ID number
UN 2512 UN 2512 UN 2512
14.2. UN proper shipping name
AMINOPHENOLS (O-, M-, P-) AMINOPHENOLS (o-, m-, p-) Aminophenols
Transport document description
UN 2512 AMINOPHENOLS (O-, M-, P-), 6.1, UN 2512 AMINOPHENOLS (o-, m-, p-), 6.1, III, UN 2512 Aminophenols, 6.1, III,
III, (E), ENVIRONMENTALLY HAZARDOUS MARINE POLLUTANT/ENVIRONMENTALLY ENVIRONMENTALLY HAZARDOUS
HAZARDOUS
14.3. Transport hazard class(es)
6.1 6.1 6.1
14.4. Packing group
III III III
14.5. Environmental hazards
Dangerous for the environment: Yes Dangerous for the environment: Yes Dangerous for the environment: Yes
Marine pollutant: Yes
No supplementary information available
14.6. Special precautions for user
Overland transport
Classification code (ADR) : T2
Special provisions (ADR) : 279
Limited quantities (ADR) : 5kg
Excepted quantities (ADR) : E1
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
Packing instructions (ADR) : P002, IBC08, LP02, R001
Special packing provisions (ADR) : B3
Mixed packing provisions (ADR) : MP10
Portable tank and bulk container instructions (ADR) : T1
Portable tank and bulk container special provisions : TP33
(ADR)
Tank code (ADR) : SGAH, L4BH
Tank special provisions (ADR) : TU15, TE19
Vehicle for tank carriage : AT
Transport category (ADR) : 2
Special provisions for carriage - Bulk (ADR) : VC1, VC2, AP7
Special provisions for carriage - Loading, unloading : CV13, CV28
and handling (ADR)
Special provisions for carriage - Operation (ADR) : S9
Hazard identification number (Kemler No.) : 60
Orange plates :
Tunnel restriction code (ADR) : E
Transport by sea
Special provisions (IMDG) : 279
Limited quantities (IMDG) : 5 kg
Excepted quantities (IMDG) : E1
Packing instructions (IMDG) : P002, LP02
IBC packing instructions (IMDG) : IBC08
IBC special provisions (IMDG) : B3
Tank instructions (IMDG) : T1
Tank special provisions (IMDG) : TP33
EmS-No. (Fire) : F-A
EmS-No. (Spillage) : S-A
Stowage category (IMDG) : A
Properties and observations (IMDG) : White or brownish (ortho-and para-) or reddish-yellow (meta-) crystals. Soluble in
water. Toxic if swallowed, by skin contact or by inhalation.
Air transport
PCA Excepted quantities (IATA) : E1
PCA Limited quantities (IATA) : Y645
PCA limited quantity max net quantity (IATA) : 10kg
PCA packing instructions (IATA) : 670
PCA max net quantity (IATA) : 100kg
CAO packing instructions (IATA) : 677
CAO max net quantity (IATA) : 200kg
Special provisions (IATA) : A113
ERG code (IATA) : 6L
14.7. Maritime transport in bulk according to IMO instruments
Not applicable
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.1.1. EU-Regulations
REACH Annex XVII (Restriction List)
Not listed on REACH Annex XVII
REACH Annex XIV (Authorisation List)
Not listed on REACH Annex XIV (Authorisation List)
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Paracetamol impurity K
Safety Data Sheet
according to the REACH Regulation (EC) 1907/2006 amended by Regulation (EU) 2020/878
REACH Candidate List (SVHC)
Not listed on the REACH Candidate List
PIC Regulation (Prior Informed Consent)
Not applicable.
POP Regulation (Persistent Organic Pollutants)
Not applicable.
Ozone Regulation (1005/2009)
Not listed on the Ozone Depletion list (Regulation EU 1005/2009)
Explosives Precursors Regulation (2019/1148)
Contains no substance(s) listed on the Explosives Precursors list (Regulation EU 2019/1148 on the marketing and use of explosives precursors)
Drug Precursors Regulation (273/2004)
Contains no substance(s) listed on the Drug Precursors list (Regulation EC 273/2004 on the manufacture and the placing on market of certain
substances used in the illicit manufacture of narcotic drugs and psychotropic substances)
15.1.2. National regulations
No additional information available
15.2. Chemical safety assessment
No additional information available
SECTION 16: Other information
Full text of H- and EUH-statements:
Acute Tox. 4 (Inhalation) Acute toxicity (inhal.), Category 4
Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4
Aquatic Acute 1 Hazardous to the aquatic environment – Acute Hazard, Category 1
Aquatic Chronic 1 Hazardous to the aquatic environment – Chronic Hazard, Category 1
H302 Harmful if swallowed.
H332 Harmful if inhaled.
H341 Suspected of causing genetic defects.
H400 Very toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.
Muta. 2 Germ cell mutagenicity, Category 2
Safety Data Sheet (SDS), EU
DISCLAIMER OF LIABILITY The EDQM has created this SDS as a downstream user for regulatory compliance to rules applicable to chemicals
only. This article is intended only for small-volume laboratory analysis and other routine testing prescribed in the pharmacopoeia or EDQM study
protocol, under controlled conditions and by professionals only. Any other use of this article or the SDS information is the sole responsibility of the
user. This substance is present in articles in quantities totalling under 10 kg per year. There is no human or environmental exposure under intended
and foreseeable conditions of use. The user has the responsibility for handling, storage, use conditions and disposal of this article and for any use
of the information in this SDS. The information has been obtained from suppliers and is without any warranty, express or implied, regarding its
correctness. For this and other reasons, we do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of
or in any way connected with the handling, storage, use or disposal of the article.
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