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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	101-72-4
Chemical Name	N-Isopropyl-N'-phenyl-p-phenylenediamine
Substance ID	H29-B-013
Classification year (FY)	FY2017
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2016 FY2008
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition).
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition).
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition).
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.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition).
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	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).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	Not applicable	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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.
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."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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).
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.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
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.
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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.
8	Specific target organ toxicity - Single exposure	Category 2 (liver, kidney, haemal 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).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, haemal 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.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (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.
11	Hazardous to the aquatic environment (Long-term)	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.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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