Item | Information |
---|---|
CAS RN | 536-90-3 |
Chemical Name | 3-Methoxyaniline; m-anisidine |
Substance ID | R02-A-049-METI, MOE |
Classification year (FY) | FY2020 |
Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
New/Revised | New |
Classification result in other fiscal year | |
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) | |
Model SDS by MHLW (External link) | |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
6 | Flammable liquids | Not classified |
- |
- | - | A flash point was 126 deg C (closed-cup) (GESTIS (Accessed Aug. 2020)). |
7 | Flammable solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
9 | Pyrophoric liquids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 545 deg C (GESTIS (Accessed Aug. 2020)). |
10 | Pyrophoric solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to liquid substances are not available. |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (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 classified (Not applicable) |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | Liquid (GHS definition) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Category 4 |
Warning |
H302 | P301+P312 P264 P270 P330 P501 |
[Rationale for the Classification] It was classified in Category 4 from (1). [Evidence Data] (1) LD50 for rats: 526 mg/kg (GLP) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law result (Ministry of Health, Labour and Welfare, 1994), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), SIDS (2002)) [Reference Data, etc.] (2) LD50 for rats: > 300 mg/kg (GLP) (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law result (Ministry of Health, Labour and Welfare, 1994), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), SIDS (2002)) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified." |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
5 | Germ cell mutagenicity | Category 2 |
Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1) to (5), it was classified in Category 2. [Evidence Data] (1) In a micronucleus test with the bone marrow cells of mice (OECD TG 474, GLP, dosed by gavage), positive (males) and negative (females) results were reported (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), SIDS (2002), HSDB (Accessed Oct. 2020)). (2) In a bacterial reverse mutation test, positive (+S9) and negative (-S9) results were reported (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), SIDS (2002), HSDB (Accessed Oct. 2020)). (3) In a bacterial reverse mutation test, negative results were reported (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), SIDS (2002), HSDB (Accessed Oct. 2020)). (4) In a chromosomal aberration test (GLP) with the Chinese hamster lung cells (CHL), negative (+S9) and positive (-S9, structural aberration) results were reported (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994)). (5) In a sister chromatid exchange (SCE) test with the Chinese hamster ovary cells (CHO), negative (+S9) and positive (-S9) results were reported (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), SIDS (2002), HSDB (Accessed Oct. 2020)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification was not possible due to lack of data. |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), it was classified in Category 1B. In (1), serious lethal action on the fetuses was observed in the early stage of implantation. [Evidence Data] (1) In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP, 50 days in total including 14 days before mating (male), from 14 days before mating through day 4 of lactation (40-49 days) (female)), at 300 mg/kg/day, general toxic effects (inhibition of body weight gain, a decrease in food consumption, changes in the tissues of the liver, spleen, etc., anemia finding (male), etc.) were observed in parent animals, but neither copulation nor fertility was affected. However, although the trace of implantation was confirmed in this group at the same level as the control group, the gestation index was 0%, and because of this, it was considered that lethal action on the fetuses occurred in the early stage of implantation. (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), SIDS (2002)). |
8 | Specific target organ toxicity - Single exposure | Category 1 (blood system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
[Rationale for the Classification] Based on (1) to (4), since methemoglobin formation and cyanosis were observed, the target organ was considered to be the blood system. Based on (1) and (2), since effects on humans were suggested, it was classified in Category 1 (blood system). [Evidence Data] (1) With regard to the systemic toxicity of the anisidines (without any differentiation of the isomers) due to occupational exposure, the anisidines trigger effects were similar to those induced by aniline, but less pronounced. It was reported that in the case of this substance (m-Anisidine), methemoglobin formation and the resulting oxygen deficiency symptoms were described as essential resorptive effects. (GESTIS (Accessed on Aug. 2020)) (2) This substance affected the blood and formed methemoglobin in some cases. It was reported that inhalation of this substance caused cyanosis, confusion, convulsion, dizziness, headache, nausea, and loss of consciousness, and these symptoms also appeared when the substance was orally dosed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)). (3) It was reported that in an acute oral toxicity test with rats (GLP), at or above 500 mg/kg (within the range for Category 2), staggering gait, salivation, lacrimation, lying on belly, a decrease in epidermal temperature, cyanosis, a decrease in locomotor activity, crouching position, etc. were observed, and in addition, brown urine was observed until the day 3 after the administration (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), SIDS (2002), HSDB (Accessed Oct. 2020)). (4) It was reported that in an acute oral toxicity test with rats (GLP), at or above 200 mg/kg (within the range for Category 1), staggering gait, salivation, and lacrimation were observed; and at 300 mg/kg (within the range for Category 1), lying on belly, and bradypnea were observed, and in addition, brown urine was observed on the day 1 after the administration (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), SIDS (2002)). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (blood system) |
Danger |
H372 | P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1), extramedullary hematopoiesis and brown pigmentation in the spleen, which were observed within the dose range for Category 1, were considered to be the effects of the hemolysis, which were observed within the dose range for Category 2, and it was classified in Category 1 (blood system). [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422, GLP, 50 days (male), 40-49 days (female)), at 2.4 mg/kg/day (converted guidance value 1.1 mg/kg/day (male), 1.3 mg/kg/day (female), within the range for Category 1) and at or above 12 mg/kg/day (converted guidance value 5.3 mg/kg/day (male), 6.7 mg/kg/day (female), within the range for Category 1), extramedullary hematopoiesis and brown pigmentation in the spleen were observed (male); at or above 60 mg/kg/day (converted guidance value 26.7 mg/kg/day (male), 33.3 mg/kg/day (female), within the range for Category 2), effects on the spleen (a decrease in lymphocytes in B-cell area, congestion (male), an increase in relative weight/brown pigmentation (female)) and effects on the blood system (decreases in red blood cell count, Hb, and Ht (male)) were observed; and at 300 mg/kg/day (converted guidance value 133 mg/kg/day (male), 167 mg/kg/day (female), in the range corresponding to "Not classified"), brown urine, effects on the spleen (an enlargement, increases in absolute and relative weight (male)), effects on the blood system (increases in reticulocyte count, leukocyte count, and neutrophil ratio, a decrease in lymphocyte ratio (male)), and effects on the liver (extramedullary hematopoiesis/brown pigmentation in Kupffer cells, an increase in relative weight (male)) were observed (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (1994), SIDS (2002)). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
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 1 |
Warning |
H400 | P273 P391 P501 |
It was classified in Category 1 from 48-hour EC50 = 0.11 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)). |
11 | Hazardous to the aquatic environment Long term (Chronic) | Category 1 |
Warning |
H410 | P273 P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 because it was not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1989)) and due to 21-day NOEC = 0.028 mg/L for crustacea (Daphnia magna) (SIDS, 2002). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 because it was not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1989)) and due to 72-hour EC50 = 10 mg/L for algae (Raphidocelis subcapitata) (Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)). By drawing a comparison between the above results, it was classified in Category 1. |
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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