NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	101-80-4
Chemical Name	4,4'-Diaminodiphenyl ether
Substance ID	m-nite-101-80-4_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is described that it is combustible (GESTIS (Access on June 2017)), but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 490 deg C (HSDB (Access on May 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2017	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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	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.	FY2017	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	FY2017	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.	FY2017	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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on a report of an LD50 value of 725 mg/kg (DFGOT Vol. 6 (1994), HSDB (Access on May 2017)) for rats, it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	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)	FY2017	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)	FY2017	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.	FY2017	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. In the previous classification, based on a description of no irritation from a test with rats (DFGOT Vol. 6 (1994)), it was classified as "Not classified." However, since the experimental conditions such as the number of animals and dosage are unknown, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. In the previous classification, based on a description of no irritation from a test with rabbits (DFGOT Vol. 6 (1994)), it was classified as "Not classified." However, since the experimental conditions such as the number of animals and dosage are unknown, it was classified as "Classification not possible."	FY2017	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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Based on a report that positive reaction was observed in 6 out of 10 animals in a test with guinea pigs (DFGOT Vol. 6 (1994)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	In carcinogenicity tests with rats and mice dosed by feeding for two years, in the rats, hepatocellular carcinomas or neoplastic nodules of the liver, and adenomas or carcinomas of the thyroid epithelial cells were observed in both sexes. In the mice, adenomas in the harderian glands and hepatocellular adenomas or carcinomas in both sexes, and adenomas of the thyroid epithelial cells in females were observed (NTP TR205 (1980), IARC 29 (1982), NTP RoC (14th, 2016)). In addition, benign or malignant tumors of the hepatocytes were also observed in the test with rats subcutaneously dosed (IARC 29 (1982), NTP RoC (14th, 2016)). As for classifications by other organizations, IARC classified it in Group 2B (IARC Suppl. 7 (1987)), NTP as R (NTP RoC (14th, 2016)), Japan Society For Occupational Health (JSOH) in Group 2B (Recommendation of Occupational Exposure Limits (2016) (proposal in 1991)), and EU in Carc. 1B (ECHA CL Inventory (Access on May 2017)). From the above, according to the classification result of IARC and JSOH, it corresponds to Category 2, but clear evidence of carcinogenicity was observed in experimental animals of two species. Therefore, it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, a decrease in the number of offspring born, a decrease in the survival rate, and jaundice were observed in the pups at 30 mg/kg/day where 4/12 maternal animals died due to delivery impairment (judged from the fact that the fetuses in the uterus had developed as a result of necropsy) (Safety Test (Ministry of Economy, Trade and Industry (METI)) (2007)). From the above, although effects on the next generation were observed in this test, general toxicity effects (effects on the liver, spleen and thyroid) were observed at 30 mg/kg/day in parental animals, therefore, it was classified in Category 2 for this hazard class. Besides, EU also classified this substance in Repr. 2 (ECHA CL Inventory (Access on May 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system), Category 2 (pituitary, thyroid, liver, kidney, reproductive organs (male))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	No information on humans is available. As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by gavage administration, decreased erythrocyte counts, an increased ratio of the reticulocytes, increased total bilirubin, and increased hemosiderin deposition in the spleen at or above 10 mg/kg/day (converted guidance value: 4.7 mg/kg/day) within the guidance value range for Category 1, and increases in ALT, AST and alkaline phosphatase activity, follicular hyperplasia of the thyroid, centrilobular hypertrophy of hepatocytes, granulation in the liver, increased extramedullary hematopoiesis in the spleen, etc. at 30 mg/kg/day (converted guidance value: 14 mg/kg/day) within the guidance value range for Category 2 were reported (Safety Test (Ministry of Economy, Trade and Industry (METI)) (2007)). In addition, in 90-day toxicity tests with rats and mice dosed by feeding, in the rats, increased mortality, alopecia, labored respiration, cyanosis, diffuse cell hyperplasia of the thyroid, pituitary hyperplasia, renal microlithiasis, testicular degeneration, atrophy of the prostate and seminal vesicle, etc. at or above 0.06% (converted guidance value: 30 mg/kg/day) within the guidance value range for Category 2 were reported. Also, in the mice, hypertrophy and hyperplasia of the thyroid at or above 0.06% (converted guidance value: 90 mg/kg/day) within the guidance value range for Category 2, testicular degeneration at or above 0.1% (converted guidance value: 150 mg/kg/day) exceeding the guidance value range for Category 2, and hypertrophy and hyperplasia of the pituitary at 0.2% (converted guidance value: 300 mg/kg/day) were reported. Moreover, in carcinogenicity tests with rats and mice dosed by feeding for two years, in the rats, hyperplasia of the thyroid follicular cells at or above 0.04% (converted guidance value: 20 mg/kg/day) within the guidance value range for Category 2, and focal mineralization of the kidney at 0.05% (converted guidance value: 25 mg/kg/day) were reported, and in the mice, hyperplasia of the thyroid follicular cells at 0.08% (converted guidance value: 120 mg/kg/day) exceeding the guidance value range for Category 2 was reported (NTP TR205 (1980), Environmental Risk Assessment for Chemical Substances Vol.9, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2011)). Among the above, as for the effects on the thyroid, they were judged to be related to the effects on the thyroid itself or the effects on the pituitary because no effect on the liver was observed in the same test. In addition, in the previous classification, the central nervous system was also regarded as the target organ, but the finding used as evidence was only lethargy, therefore, it was not adopted as the target organ. Therefore, it was classified in Category 1 (haemal system), Category 2 (pituitary, thyroid, liver, kidney, genetic organs (men)). Besides, the classification result was different from the previous one due to the use of new information sources.	FY2017	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.	FY2017	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 1	Warning	H400	P273 P391 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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