Item | Information |
---|---|
CAS RN | 90-04-0 |
Chemical Name | o-Anisidine |
Substance ID | R03-C-011-MHLW, MOE |
Classification year (FY) | FY2021 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | Revised |
Classification result in other fiscal year | FY2018 FY2009 FY2006 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | - |
- |
- | - | - |
2 | Flammable gases | - |
- |
- | - | - |
3 | Aerosols | - |
- |
- | - | - |
4 | Oxidizing gases | - |
- |
- | - | - |
5 | Gases under pressure | - |
- |
- | - | - |
6 | Flammable liquids | - |
- |
- | - | - |
7 | Flammable solids | - |
- |
- | - | - |
8 | Self-reactive substances and mixtures | - |
- |
- | - | - |
9 | Pyrophoric liquids | - |
- |
- | - | - |
10 | Pyrophoric solids | - |
- |
- | - | - |
11 | Self-heating substances and mixtures | - |
- |
- | - | - |
12 | Substances and mixtures which, in contact with water, emit flammable gases | - |
- |
- | - | - |
13 | Oxidizing liquids | - |
- |
- | - | - |
14 | Oxidizing solids | - |
- |
- | - | - |
15 | Organic peroxides | - |
- |
- | - | - |
16 | Corrosive to metals | - |
- |
- | - | - |
17 | Desensitized explosives | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | - |
- |
- | - | - |
1 | Acute toxicity (Dermal) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Gases) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Vapours) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Dusts and mists) | - |
- |
- | - | - |
2 | Skin corrosion/irritation | - |
- |
- | - | - |
3 | Serious eye damage/eye irritation | - |
- |
- | - | - |
4 | Respiratory sensitization | - |
- |
- | - | - |
4 | Skin sensitization | - |
- |
- | - | - |
5 | Germ cell mutagenicity | - |
- |
- | - | - |
6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) to (6), it was classified in Category 1B. [Evidence Data] (1) As for the classification results by domestic and international organizations, the IARC changed the category from the previous Group 2B (IARC 73 (1999)) to Group 2A (IARC 127 (2021)) based on the data in (2) to (5). The NTP classified it in R (NTP RoC (14th, 2016)) and the EU classified it in Carc. 1B (EU-CLP Classification Results (Accessed Sep. 2021)). Also, the ACGIH classified it in A3 (ACGIH (7th, 2001)), the Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH) (1997) and the DFG classified it in Carc. 2 (DFG MAK (2021)). (2) It was reported that, in a carcinogenicity study for hydrochloride of this substance (o-anisidine hydrochloride: CAS RN 134-29-2) used as a test substance with rats dosed by feeding for two years, bladder tumors (transitional cell carcinoma, transitional cell papilloma + carcinoma) in males and females and renal pelvis tumors (transitional cell carcinoma) and thyroid tumors (follicular cell adenoma + cystadenoma + papillary cystadenoma + follicular cell carcinoma + papillary cystadenocarcinoma) in males were observed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2009), IARC 127 (2021), EU RAR (2002), ACGIH (2001), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH) (1996), NTP TR89 (1978)). (3) It was reported that, in a carcinogenicity study for o-anisidine hydrochloride used as a test substance with mice dosed by feeding for two years, bladder tumors (transitional cell carcinoma, transitional cell papilloma + carcinoma) in males and females were observed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2009), IARC 127 (2021), EU RAR (2002), ACGIH (2001), Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH) (1996), NTP TR89 (1978)). (4) This substance, which is a parent compound of o-anisidine hydrochloride, is a basic compound and will undergo acid-base reactions, and o-anisidine and its hydrochloride salt will achieve a pH-dependent acid-base equilibrium in the body. Therefore, the classification of carcinogenic hazard applies to both o-anisidine and its hydrochloride salt (IARC 127 (2021)). (5) As a result of consideration of the mechanism of action of this substance, there was strong evidence that this substance had a mechanism of action common to a class of aromatic amines for which several member compounds had been classified as known human carcinogens. This substance had structural similarity to other member compounds of this class, and there was concordance with respect to the bioactivation mechanism to DNA-reactive moieties, genotoxicity and target organs of carcinogenicity in long-term animal tests (IARC 127 (2021)). (6) Although there was inadequate evidence in humans regarding the carcinogenicity of this substance, The IARC concluded that both this substance and its hydrochloride were classified in Group 2A for carcinogenicity based on (2) to (5) (IARC 127 (2021)). |
7 | Reproductive toxicity | - |
- |
- | - | - |
8 | Specific target organ toxicity - Single exposure | - |
- |
- | - | - |
9 | Specific target organ toxicity - Repeated exposure | - |
- |
- | - | - |
10 | Aspiration hazard | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | Category 2 |
- |
H401 | P273 P501 |
It was classified in Category 2 from 48-hour EC50 = 2.18 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021)). |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 2 |
- |
H411 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN) and 21-day NOEC = 0.25 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1996), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified as "Not classified" due to being not rapidly degradable and 96-hour LC50 = 196 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1996), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2021)). By drawing a comparison between the above results, it was classified in Category 2. The classification result was revised from the previous classification by changing how to classify it in chronic toxicity and using new information. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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