NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	101-72-4
Chemical Name	N-Isopropyl-N'-phenyl-p-phenylenediamine
Substance ID	m-nite-101-72-4_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)	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 (ICSC (J) (1999)), 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	Classification not possible	- -	-	-	No data available.	FY2017	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.	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)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	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 reports of LD50 values for rats of 522 mg/kg (male), 701 mg/kg (female) (JECDB (Access on May 2017)), 800 mg/kg, and 900 mg/kg (SIDS (2004)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports that there were no deaths in a dermal application of 5,010 mg/kg or 7,940 mg/kg to rabbit skin (SIDS (2004)), it was classified as "Not classified."	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	Not classified	- -	-	-	Based on the following reports of the tests with rabbits: no irritation was observed (SIDS (2004)); slight irritation was observed, but this disappeared after 24 hours (DFGOT Vol. 1 (2016) (Access on May 2017)), it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2017	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 a report that in a test with rabbits, conjunctival erythema was observed after 24 hours in all the animals, but this disappeared after 48 hours (SIDS (2004)), it was classified in Category 2B.	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 in a skin sensitization test with guinea pigs, a positive reaction was shown in 70% of 20 animals (SIDS (2004)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a mouse bone marrow sister chromatid exchange test was negative (DFGOT (2013) (Access on May 2017)). As for in vitro, bacterial reverse mutation tests were negative, a mouse lymphoma test and gene mutation tests with mammalian cultured cells were negative, and a chromosome aberration test and a sister chromatid exchange test were positive (JECDB (Access on May 2017), DFGOT Vol. 1 (2016) (Access on May 2017), SIDS (2004)). From the above, it was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	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))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a developmental toxicity study with pregnant rats dosed by gavage during the organogenesis period, in the high dose (125 mg/kg/day) group, no abnormalities other than clinical symptoms were observed in maternal animals. In the fetuses, incomplete ossification of the cranial and facial bones, and no ossification of the hyoid were observed in the high dose group. However, these were considered to be due to the delayed ossification which was not regarded as evidence of classification (SIDS (2004)). There are no other data of a developmental toxicity test, and there is no information on the effects on fertility and sexual function either. Therefore, classification was not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (liver, kidney, blood system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	There is no information on single exposure to this substance in humans. As for experimental animals, there is a report that in a single oral administration test with rats, in the surviving cases in the group dosed at or above 455 mg/kg corresponding to Category 2, the following was observed: in the liver, hypertrophy of centrilobular hepatocytes, increased mitotic figures of hepatocytes, and extramedullary hematopoiesis; in the kidney, the tubular regeneration and lymphocytic infiltration in the medulla; and in the spleen, severely increased extramedullary hematopoiesis. Moreover, in these animals, pale skin was observed, and it is considered that this suggests the possibility that hemolytic anemia occurred (JECDB (Access on May 2017)). From the above, it was classified in Category 2 (liver, kidney, haemal system).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, blood system), Category 2 (kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	No information on humans is available. As for experimental animals, there is a report that in a 28-day repeated oral dose toxicity test with rats dosed by gavage, at or above 30 mg/kg/day (converted guidance value: 9.3 mg/kg/day) within the guidance value range for Category 1, a decrease in mean corpuscular volume, an increase in the granulocytic myelocytes of the bone marrow cells, enlarged liver, eosinophilic hypertrophy of hepatocytes, fatty change in the intermediate zone of the liver lobule, hemosiderin deposition in the spleen, etc., at or above 100 mg/kg/day (converted guidance value: 31.1 mg/kg/day) within a guidance value range for Category 2, decreased body weight/depressed body weight gain, decreases in the red blood cell, hemoglobin and hematocrit value, increases in the reticulocyte ratio and in the platelet count, a decrease in the lymphocyte ratio, an increase in the neutrophil ratio, single cell necrosis of hepatocytes, enlarged spleen, hemosiderin deposition and an increase in extramedullary hematopoiesis in the spleen, an increase in kidney weights, an increase in basophilic tubules and hemosiderin deposition in the kidneys were reported (JECDB (Access on May 2017)). In a 90-day repeated oral dose toxicity test with rats dosed by feeding, at or above 500 ppm (male: 43.8 mg/kg/day (converted guidance value: 13.6 mg/kg/day), female: 48.1 mg/kg/day (converted guidance value: 15.0 mg/kg/day)) within a guidance value range for Category 2, an increase in total protein, an increase in relative liver weight, at or above 1,000 ppm (male: 92.6 mg/kg/day (converted guidance value: 28.8 mg/kg/day), female: 92.8 mg/kg/day (converted guidance value: 28.9 mg/kg/day)), an increase in the platelets, an increase in the white blood cells, an increase in segmented neutrophils, decreases in the hemoglobin and hematocrit value, anisocytosis, an increase in dysmorphic erythrocytes, increases in absolute and relative spleen weights were reported (DFGOT Vol. 1 (2016) (Access on May 2017)). From the above, it was classified in Category 1 (liver, haemal system), Category 2 (kidney). Besides, in the previous classification, it was assumed that the effects on the haemal system were observed at or above 100 mg/kg/day (converted guidance value: 31 mg/kg/day) within the guidance value range for Category 2. But, it was judged that these effects were observed at or above 30 mg/kg/day (converted guidance value: 9.3 mg/kg/day) within a guidance value range for Category 1. Therefore, the classification was changed.	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	From 96-hour LC50 = 0.34 mg/L for fish (Oncorhynchus mykiss) (OECD SIDS: 2000), it was classified in Category 1.	FY2017	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	Chronic toxicity data were not obtained. Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 2.2% and 19.7%, was regarded as an outlier and not adopted (J-CHECK, 1994)), and acute toxicity Category 1, it was classified in Category 1.	FY2017	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.	FY2017	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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