NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	536-90-3
Chemical Name	3-Methoxyaniline; m-anisidine
Substance ID	m-nite-536-90-3_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)
Sample SDS by MHLW (External link)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified	- -	-	-	A flash point was 126 deg C (closed-cup) (GESTIS (Accessed Aug. 2020)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification was not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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