NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	86-30-6
Chemical Name	N-Nitrosodiphenylamine
Substance ID	m-nite-86-30-6_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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (N-O) present in the molecule, and calculated oxygen balance is lower than -200 (-218). However, because the exothermic decomposition energy at 300-500 deg C is above 500 J/g (650 J/g, Bretherick(J) (5th, 1998)), the classification is not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is combustible (ICSC (2003)), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It is a nitroso compound containing a chemical group associated with explosive properties (N-O), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (N), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)	Not classified	- -	-	-	Based on the LD50 value of 3,000 mg/kg for rats (PATTY (6th, 2012), IARC 27 (1982), ATSDR (1993), NTP TR164 (1979)), this substance was classified as "Not classified" (Category 5 in UN GHS classification). 　Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence for classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value of > 7,940 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances vol.4 (Ministry of the Environment, 2005)), this substance was classified as "Not classified" (Category 5 in UN GHS classification). 　Besides, the Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, it is described that in a skin irritation test using rabbits, no irritation was observed, but the details are unknown (Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). In addition, the information in ATSDR adopted in the previous classification was not adopted in this classification because it is described as an insufficient test in ATSDR.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on the report that in an eye irritation test using rabbits, slight irritation of the eyes was observed, this substance was classified in Category 2B. 　Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible," because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. 　As for in vivo, micronucleus tests using mouse bone marrow cells and DNA damage tests using rat livers were negative (ATSDR (1993), Environmental Risk Assessment for Chemical Substances vol.4 (Ministry of the Environment, 2005)). 　As for in vitro, bacterial reverse mutation tests were negative or positive, the mammalian cell gene mutation tests were negative, mouse lymphoma assays were negative or positive, the chromosomal aberration tests and sister chromatid exchange tests were negative or positive (NTP DB (Access on October 2016), ATSDR (1993), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), IARC 27 (1982)). 　Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In 2-year carcinogenicity studies using rats or mice administered by feeding, no evidence of carcinogenicity was observed in mice, but in rats, an increase in the incidence of transitional-cell carcinomas of the bladder was observed in both males and females in the high dose group (IARC 27 (1982), IRIS (1987)). 　Although there is limited evidence for carcinogenicity in experimental animals, there is insufficient data on humans, so IARC classified this substance in Category 3 (IARC Suppl. 7 (1987)). 　On the other hand, the EPA classified this substance in B2 (equivalent to Category 1B) based on the increased incidence of reticulum cell sarcomas in a single dose study administered subcutaneously using male mice and structural relationship to nitrosamines, carcinogens in addition to carcinomas of the bladder in rats (IRIS (1987)). 　As described above, the classification results by both organizations are different and this substance is an N-nitroso compound, so this substance could be classified in Category 1B. Classification in Category 2 was judged to be appropriate based on the carcinogenicity result of only one experimental animal species.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	There is no single exposure data on this substance in humans. 　As for experimental animals, it is described that in a single oral dose study using rats, animals died after showing decrease in food consumption, decrease in locomotor activity, exhaustion, tremors, and prostration at 1,825 mg/kg, which is equivalent to Category 2 (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). 　This substance was classified in Category 2 (systemic toxicity) because it is not possible to specify target organs from these symptoms. 　Besides, Chemical Substance Hazard Data (CERI, 1998) used in the previous classification was not adopted as evidence of classification, because this information is listed as List 3 information sources in the GHS classification guidance for the Japanese government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (urinary bladder)	Warning	H373	P260 P314 P501	As for humans, there was no information that could identify adverse effects of this substance. 　As for experimental animals, carcinogenicity studies were conducted using rats and mice administered by feeding. 　In rats, hyperplasia of transitional epithelium cells in the urinary bladder was observed at 50 mg/kg/day, which is equivalent to Category 2, and in mice, epithelial hyperplasia in the urinary bladder and chronic inflammation of submucosal tissues were observed at 1,300 mg/kg/day or more in males, which is above Category 2, and at 301 mg/kg/day or more in females (NTP TR164 (1979), Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005)). 　Therefore, this substance was classified in Category 2 (urinary bladder). 　Besides, the evidence data for the classification in Category 2 (respiratory organs, liver, kidneys) in the previous classification is a study using rabbits, and there is a description that details on this study are unknown in Environmental Risk Assessment for Chemical Substances Vol. 4 (Ministry of the Environment, 2005), so it was not adopted.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 2	- -	H401	P273 P501	From 48-hour LC50 = 7.8 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)), it was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and 21-day NOEC (reproduction) = 0.075 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)). 　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 being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1980)), and 96-hour LC50 = 10.2 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1996), Environmental Risk Assessment for Chemical Substances vol. 2 (Ministry of the Environment, 2003), Environmental Risk Assessment for Chemical Substances vol. 4 (Ministry of the Environment, 2005)). 　It was classified in Category 1 from the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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