GHS Classification Result （Revision of the past classification result）

Chemical Name：o-Anisidine
CAS：90-04-0

Result：
ID: 21B3094
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government （March, 2009）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Not classified - - - - It is judged that flash point is >93 degC under closed-cup test method since data are available that flash point is 118 degC (open-cup) (ICSC (1999)).
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not classified - - - - Auto-ignition point is 415 degC (ICSC (1999)) exceeding 70 degC.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		Based on LD50 values of 2000 mg/kg (ACGIH (2001)), 1890 mg/kg (EU-RAR (2002)) and 1150 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 4 (2005)) for rats, the substance was classified into Category 4.
1 Acute toxicity （Dermal） Not classified - - - - Based on no mortality at 2000 mg/kg in rats (EU-RAR (2002)), the substance was classified as "Not classified".
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - A LC50 (aerosol) value was >3.87 mg/L (EU-RAR (2002)). Classification was not possible since determination of the category was impossible.
2 Skin corrosion/irritation Not classified - - - - In a rabbit dermal irritation test (OECD TG404), erythema and slight edema reactions were observed and disappeared within 72-hour after patch removal (EU-RAR (2002)). Based on the report, the substance was classified as "Not classified" in JIS Classification (correspond to Category 3 in GHS classification).
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling. 		In a rabbit eye irritation test (OECD TG405), chemosis, reddening of the conjunctivae, iritis and keratitis were observed and disappeared within 7 days after application (EU-RAR (2002)). Based on the report, the substance was classified into Category 2B.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Although a weak positive result was obtained in a guinea pig skin sensitization test, there are uncertainties about the test's adequacy due to insufficient documentation (EU-RAR (2002)). In a mouse local lymph node assay (OECD TG429), o-aminophenols which may be formed in the metabolism of o-anisidine, had produced a dose related positive response. However, the response for the structural analogue o-phenetidine was negative. Overall, uncertainty remains as to whether or not the substance possesses skin sensitizing potential (EU-RAR (2000)), classification was not possible due to lack of sufficient data.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Although there are negative results in a mouse bone marrow micronucleus test and a rat hepatic cell micronucleus test (in vivo somatic cell mutagenicity tests) (DFGOT vol. 10 (1998)), the substance was classified into Category 2 based on positive result in a Big Blue transgenic mouse mutagenicity test (EU-RAR (2002)). Positive results are also reported from other in vivo tests including DNA synthesis test, DNA adduct formation test and host-mediated test (DFGOT vol. 10 (1998)). As relevant information, from in vitro mutagenicity tests, there are reports of both positive and negative results in Ames tests and chromosomal aberration tests using CHO cells and human lymphocytes (with or without S9). In addition, the substance is classified into Category 3 for Mutagenicity; R68 in EU classification.
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the classification of "2B" in IARC (IARC 73 (1999)), the substance was classified into Category 2. As relevant information, the substance is classified into "A3" in ACGIH (ACGIH (2001)). In 2-year feeding tests in rats and mice, significantly increased incidences of transitional-cell carcinomas of the urinary bladder and renal pelvis were observed in rats, and significantly increased incidences of transitional-cell carcinomas/papillomas of the urinary bladder were observed in mice (IARC 27 (1982)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Category 2 (blood, central nervous system) Warning H371: May cause damage to organs (blood, central nervous system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In rats, the single oral application via gavage of 690 mg/kg or more resulted in significantly elevated methaemoglobin levels (EU-RAR (2002)). In another oral test with rats (DFGOT vol. 10 (1998), EU-RAR (2002)), neurologic symptoms such as squatting, staggering gait, reduced spontaneous activity and dizziness were noted at dose levels of 1250 - 2000 mg/kg. In addition, slight impairment in the breathing and reflexes was seen after inhalation exposure of rats to concentration of 3.87 mg/L. (DFGOT vol. 10 (1998)). Based on the data, the substance was classified into Category 2 (blood system, central nervous system).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		Based on a report of a 4-week oral test with rats where hemolytic anemia was observed at dose levels of 80 mg/kg (90-day equivalence: 24.8 mg/kg) or higher (EU-RAR (2002), DFGOT vol. 10 (1998)), the substance was classified into Category 2 (blood system). For humans, there is a report that no anaemia occurred in workers exposed for 6 months to o-anisidine concentrations of 0.4 mg/m3 for 3.5-hour/day but increased sulfhaemoglobin and methaemoglobin values and Heinz bodies in the erythrocytes were detected (DFGOT vol. 10 (1998)). However, this data was not used as the basis of classification because of the availability of only one report.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 48h-EC50 = 6800 microg/L for Crustacea (Daphnia magna) (Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment), vol. 2, 2003).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since it is rapidly degradable (TOC degradation rate: 92.9, 72.3% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1977)) and low bioaccumulative potential is estimated (log Kow = 1.18 (PHYSPROP Database, 2009)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information