NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	100-01-6
Chemical Name	p-Nitroaniline
Substance ID	m-nite-100-01-6_v2
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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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	- -	-	-	UNRTDG Class: 6.1	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	Not classified	- -	-	-	UNRTDG Class: 6.1	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified	- -	-	-	Classified in UNRTDG Class: 6.1	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	- -	-	-	Flash point: 510degC (Hommel, 1991, Card No.293)	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Not classified	- -	-	-	UNRTDG Class: 6.1	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	- -	-	-	UNRTDG Class: 6.1	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	Not classified	- -	-	-	UNRTDG Class: 6.1	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	Calculated based on rat LD50 value: 3249mg/kg (Japan Society for Occupational Health advice, 1995), 3250mg/kg (CERI Hazard Data, 2002), and 750mg/kg (CERI Hazard Data, 2002). Since the calculated values was 1049mg/kg, it was set as Category 4.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	There was description of rat LD50 value:>2500mg/kg in IUCLID (2000). But there was no other data and it was not able to judge Category 5 or outside of Category, itcannot be classified.	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	Not classified	- -	-	-	In the application test on rabbit skin, irritation was not observed (CERI Hazard Data (2002)), therefore, it was classified as out of Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	There is description that irritation was not admitted in the test applied to the eye of the rabbit (CERI Hazard Data (2002)). But there is description that an eye was slightly stimulated as human impact (ACGIH (7th, 2001)). It was not clear about the irritation presence to eyes, it could not be classified.	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	Not classified	- -	-	-	Classified as out of category because CERI Hazard Data Category (2002) describes that a test using guinea pigs finds no sensitization.	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was regarded as outside the categories because there is a record of a negative result from the micronucleus test (subjected tissue unknown), which is an in vivo mutagenicity test in IUCLID (2000).	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] In (1) and (2), negative results were obtained for carcinogenicity in female mice, and male and female rats. In contrast, although a slight increase in the incidence of hemangiosarcoma of the liver was observed in male mice, it was regarded as an equivocal result and it was considered appropriate not to judge carcinogenicity from the current information. Therefore, this substance was classified as "Classification not possible." Based on the new findings, the classification result was changed. [Evidence Data] (1) In a two-year carcinogenicity study with mice dosed by gavage, a slight increase in the incidence of hemangiosarcoma of the liver was observed in males, but the NTP which conducted the study concluded that it was equivocal evidence. There was no evidence of carcinogenicity in females (NTP TR428 (1993), ACGIH (2001), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995), NICNAS IMAP (2017), HSDB (Accessed November 2021), Chemical Substance Hazard Data (CERI, 2002)). (2) In a two-year chronic toxicity/carcinogenicity study with rats dosed by gavage, no increase of tumors was observed (ACGIH (2001), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995), NICNAS IMAP (2017), HSDB (Accessed November 2021), Chemical Substance Hazard Data (CERI, 2002)). (3) As for the classification results by domestic and international evaluation organizations, the DFG classified it in Category 3 because a carcinogenic potential could not be ruled out based on (2) (List of MAK and BAT values 2020 (Accessed Oct. 2021)) but concluded that the data was not sufficient. In addition, the ACGIH classified it in A4 (ACGIH (2001)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There is the description that there is the increased of number of resorptions and fetal malformations only in the dose causing general toxicity to dam animals in peroral administration during pregnancy using rat (ACGIH (7th, 2001), PATTY (4th, 1994), CERI Hazard Data, and NTP TR418 (1993)). And it was considered as in the Category 2.	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 1 (blood), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Due to the descriptions that methaemoglobinaemia, giddiness and consciousness loss were observed in human accidental exposure in industrial hygene academic society advice (1995), ACGIH (7th, 2001), PATTY (4th, 1994), and CERI Hazard Data (2002), and that somnolence and convulsion were observed by oral administration to the guinea pigs in CERI Hazard Data (2002). So blood is the internal target organ, and it is judged that it has anesthetic actions. Ttherefore, it was classified into Category 3 (anesthesia action).	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood)	Danger	H372	P260 P264 P270 P314 P501	In industrial hygene academic society advice (1995), ACGIH (7th, 2001), CERI Hazard Data (2002), and NTP TR418 (1993), due to the description that the effect to the blood on methemoglobinemia etc. was observed within the dosage of the guidance value range of Category 1 in the two-week oral study using mouse or the four-week inhalation atmospheric exposure test using rats , 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 3	- -	H402	P273 P501	From 48-hour EC50 = 22 mg/L for crustacea (Daphnia magna) (Results of Ecotoxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2011), it was classified in Category 3.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
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 lack of rapid degradability (a degradation rate by BOD: 0% (the existing chemicals survey program, 1977)), and 72-hour NOEC = 0.94 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Ecotoxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2011). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to lack of rapid degradability (a degradation rate by BOD: 0% (the existing chemicals survey program, 1977)), and 48-hour EC50 = 22 mg/L for crustacea (Daphnia magna) (Results of Ecotoxicity tests of chemicals conducted by Ministry of the Environment in Japan, 2011). It was classified in Category 2 by drawing a comparison between the above results.	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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