NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	104-94-9
Chemical Name	p-Anisidine
Substance ID	m-nite-104-94-9_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 molecules.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified	- -	-	-	Not ignite spontaneously on coming into contact with air at normal temperatures	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen and the oxygen is chemically bonded only to carbon and hydrogen (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2006	GHS Classification Manual （10 Feb, 2006）
17	Desensitized explosives	-	- -	-	-	-	-	-

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	It was set as Category 4 based on Rat LD50 value: 1400mg/kg (ACGIH 7th, 2001, IARC 27, 1982, Japan Society for Occupational Health recomendation, 1996).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	-	- Warning	-	-	It was set as Category 5 based on rat LD50 value: 3200mg/kg (Japan Society for Occupational Health recommendation, 1996).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification is not possible due to lack of data. Although there is information (1), it was not used for the classification because test details are unknown. [Reference Data, etc.] (1) It is reported that in a skin irritation test with rabbits (OECD TG404), after 4-hour application of this substance, irritation was not found (DFGOT (2001), REACH registration dossier (Accessed Dec. 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Insufficient data available.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification is not possible due to lack of data. It is reported that it was not sensitizing in an animal test (3), but test details are unknown, and knowledge in humans was not sufficient, therefore, these were not used for the classification. Besides, o-anisidine was classified in Category 1 in skin sensitization (please refer to CAS: 90-04-0). [Reference Data, etc.] (1) In the announcement No. 33 of the Ministry of Labour (1996) (revised by the announcement No. 316 of the Ministry of Health, Labour and Welfare, 2013), this substance was designated as "anisidine" in Simple chemical substances or compounds designated by the Minister of Health, Labour and Welfare based on Appended Table 1-2, (iv) 1 of the Ordinance for Enforcement of the Labor Standards Act, and a disease principally having specific symptoms and disorders (subjective symptoms such as headaches, dizziness, and vomiting, and skin disorders, hemolytic anemia, or methemoglobinemia) due to work involving exposure to this substance was designated as an occupational disease by the Minister of Health, Labour and Welfare. (2) In the notice No. 0811001 issued by Director of Labour Standards Bureau, the Ministry of Labour (2003), this substance was designated as "anisidine" among hazardous substances for which installation of protective equipment to prevent skin disorders is mandated in Article 594 in the Industrial Safety and Health Regulations. (3) It is reported that in a skin sensitization test with guinea pigs, this substance was not a skin sensitizer (DFGOT (2001)). (4) It is reported that information on sensitizing potential of this substance was not confirmed in animal experiments and case reports (GESTIS (Accessed Dec. 2018))	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Although there are positive results from the multiple-parameter in vitro mutagenicity tests (the bacterial reverse mutation test and the chromosome aberration test using mammalian cultured cells) (ACGIH 7th, 2001, NTP DB, 2006), there are also negative results from the bacterial reverse mutation tests (NTP DB, 2006, IARC 27, 1982, Japan Society of Occupational Health Recommendations, 1996). So it was decided that the substance could not be classified due to insufficient data.	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Not classified	- -	-	-	It is classified into A4 (ACGIH 7th, 2001) according to ACGIH and classified into group 3 (IARC Suppl.7, 1987) according to IARC. So it was set as the outside of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 1 (blood)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Due to the description that cyanosis occurred by methemoglobinemia in human exposure in industrial hygene academic society advice (1996), it was classified into Category 1 (blood).	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood)	Danger	H372	P260 P264 P270 P314 P501	Due to the description that anemia and reticulocytosis increasing were observed within the concentration of the guidance value range of Category 1 in the inhalation exposure test using mice in ACGIH (7th, 2001), it was classified into Category 1 (blood) .	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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	From 48-hour EC50 = 0.18 mg/L for crustacea (Daphnia magna) (Result of the initial environmental risk assessment of chemicals, Vol. 3, Ministry of the Environment in Japan, 2004), it was classified in Category 1.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	It was classified in Category 3 from rapid degradability (a degradation rate by BOD: 65.3% (the existing chemicals survey program, 1977)), and 21-day NOEC = 0.125 mg/L for crustacea (Daphnia magna) (Ecotoxicity tests, Environment Agency, 1995; Result of the initial environmental risk assessment of chemicals, Vol. 3, Ministry of the Environment in Japan, 2004).	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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