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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	H28-B-060, C-126B
Classification year (FY)	FY2016
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	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	- -	-	-	No data available. Besides, it is written that it is combustible (ICSC(J) (1999)).
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 the LD50 values (OECD TG 401) of 522 mg/kg (males) and 701 mg/kg (females) for rats (JECDB (Access on September 2016)), this substance was classified in Category 4.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the description that in a study using rabbits applied dermally with this substance as a 40% solution in corn oil, no deaths were observed at doses of 5,010 mg/kg and 7,940 mg/kg (SIDS (2004)), therefore, this substance 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	- -	-	-	In a skin irritation test using rabbits (applied for 24 hours), no irritation was observed in any of the animals at 4, 24, 48, 72, 168 hours after application (SIDS (2004)). In addition, this substance exhibited either negative or slightly irritating to the skin of rabbits and humans, but it was concluded that this substance was not a skin irritant (SIDS (2004)). Therefore, the substance was classified as "Not classified."
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In an eye irritation test using rabbits, very slight erythema was observed in the conjunctivas of all the animals after 24 hours. This had disappeared after 48 hours (SIDS (2004)). In addition, although this substance exhibited either negative or slightly irritating to the eyes, it was concluded that this substance was not an eye irritant (SIDS (2004)). Therefore, the substance was classified as "Not classified." Besides, in the previous classification, the substance was classified in Category 2B based on the data from IUCLID, which was not available this time.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Since in a skin sensitization test (maximization test) using guinea pigs, the rate of sensitization was 70% from intradermal injections of 0.5%, and in a skin sensitization test (local lymph node assay) using mice, the EC3 value was 0.5% or less (SIDS (2004)), therefore, this substance was classified in Category 1A. Besides, this substance is classified as "Skin. Sens. 1 H317" in EU CLP classification (ECHA CL Inventory (Access on September 2016)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no in vivo data. As for in vitro, bacterial reverse mutation tests, and mammalian cell gene mutation assays and mouse lymphoma assay all were negative, and chromosome aberration tests and sister chromatid exchange tests using cultured mammalian cells were positive (JECDB (Access on September 2016), NTP DB (Access on September 2016), SIDS (2004)). Besides, there was a description from BUA (1996) in the previous classification, but that information could not be confirmed. In addition, because IUCLID (2000) in the previous classification was not available, it could not be confirmed either.
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, in a developmental toxicity study in pregnant rats given by gavage on the organogenesis period (Days 6-15 gestation), it is reported that no maternal toxicity was observed at the highest dose of 125 mg/kg/day. In fetuses, minor effects which could not be adopted as classification evidence such as ossification retardation and skeletal variations were observed (SIDS (2004)).
8	Specific target organ toxicity - Single exposure	Category 2 (liver, kidney, haemal system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In a single dose study using rats orally given this substance, transient decreases in body weights or suppressed body weight gain were observed in all the dosed groups. In addition, a crouching position, eyelid closure and decrease in fecal volume were observed. Moreover, the possibility of hemolysis was suggested because temporary pale skin was observed. In the case of dead animals, staggering, lacrimation, prone position, decreased respiration and hypothermia were observed. In the necropsy results of the surviving animals, effects on the liver (hypertrophy of centrilobular hepatocytes, increased mitosis of hepatocytes, extramedullary hematopoiesis), kidney (regenerated renal tubules in kidney medulla, cellular infiltration of lymphocytes) and spleen (extramedullary hematopoiesis) were observed. Moreover, in the case of dead animals, necrosis or degeneration of centrilobular hepatocytes was observed in the groups administered at 592 mg/kg or above (JECDB (Access on September 2016)). From the above results, this substance was classified in Category 2 (liver, kidney, haemal system).
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver), Category 2 (haemal system, kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information on humans. As for experimental animals, in a 28-day repeated dose toxicity study using rats administered by gavage, decrease in the mean corpuscular volume (males), increase in the myeloid granulocytic myelocyte ratio (females), increase in liver weights, enlargement of the liver, eosinophilic hypertrophy of hepatocytes, fatty change in the intermediate zone of the liver lobules and hemosiderin deposition in the spleen, etc. were observed at not less than 30 mg/kg (converted guidance value: 9 mg/kg/day), which is equivalent to Category 1. Additionally, decreases in the red blood cell count, hemoglobin content and hematocrit value, increases in reticulocyte and platelet count, decrease in the lymphocyte ratio, increase in neutrophill ratios, increase in total bilirubin, fatty change in the intermediate zone of the liver lobules, single cell necrosis of hepatocytes, increase in spleen weights, enlargement of the spleen, hemosiderin deposition and increase in extramedullary hematopoiesis in the spleen, increase in kidney weights, basophilic tubules, hemosiderin deposition in the kidney etc. were observed at 100 mg/kg/day (converted guidance value: 31 mg/kg/day), which is equivalent to Category 2 (JECDB (Access on September 2016)). As described above, the effects on the liver and haemal system from the dose equivalent to Category 1 were observed, and effects on the kidneys were observed at the dose equivalent to Category 2. However, it was judged that effects on the haemal system were clear in Category 2. Therefore, this substance was classified in Category 1 (liver) and Category 2 (haemal system, kidney).
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) (SIDS, 2004), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (BIOWIN), 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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