NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	793-24-8
Chemical Name	N-(1,3-Dimethylbutyl)-N'-phenyl-1,4-phenylenediamine
Substance ID	m-nite-793-24-8_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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition temperature 500degC (ICSC,2006)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	The test method applicable for substances becoming liquid or gas at 140degC of test temperature has not been established.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is an organic compound not containing oxygen, fluorine or chlorine.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	The organic compound not including peroxy group in molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	It was classified into Category 4 from low value of 893 mg/kg of LD50 value of 1,005 mg/kg (male) and 893 mg/kg (female) (SIDS (2004)) of the acute oral toxicity test (OECD TG 401, GLP) employing a rat.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From a description of LD50 value of >7,940 mg/kg (female) (SIDS (2004)) in the dermal administration test employing rabbits, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on the description, " The average score of the 6 animals is less stimulative than 0.0/8.0,"(SIDS (2004)) in the 4-hour study with rabbits, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	From the description of "The average score of six rabbits after 24 hours is 20.6/110 and the redness and edema disappeared on the 5th day." in the Draize test employing rabbits (SIDS (2004)), it was classified into Category 2B.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	About humans, since there are descriptions in two or more patch tests that "5 of 9 contact dermatitis patients were positive" and that "17 of 50 volunteers were positive" (both in SIDS (2004)), and from a description of "the judgement of medium sensitization in 50% at 0.05% of concentration and the judgement of very high sensitization in 90% at 0.5% of concentration" in the Maximization tests employing 20 female guinea pig (SIDS (2004)), it was classified as Category 1. It has been described that "a repeated and long-term contact may cause skin sensitization" in the paragraph of the influence of long- term or repeated exposure of ICSC (2006).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	From the description that the body cell in vivo mutagenicity tests (the micronucleus test (GLP) employing a mouse, chromosome aberration test using a rat (GLP)) are "negative" (SIDS (2004)), it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Since no evaluation by major international evaluation agencies is made and there is a description that "there is no research example with sufficient evidence" (SIDS (2004)), classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Not classified	- -	-	-	There is a description in the 3 generation mixed food administration study with female and male rats as follows, "Although body weight reduction was observed in the medium dose group and high dose group from E0 generation to F3 generation (75mg/kg), no effect was found on reproductive functions and activities and there was no histopathological change. "The number of live pups was same in all generations" (SIDS (2004). Moreover, there is a description in the reproductive/developmental toxicity screening study using rats (OECD TG 421, GLP)as follows, "There was no effect on denital functions and no effect was observed among child animals at the dose level where liver hypertrophy and vacuolar degeneration were recognized among females and males" (The Ministry of Health, Labour and Welfare Report (Access on September 2008). For the reasons stated above, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 3 (Narcotic effects)	Warning	H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	In the acute oral toxicity test employing rats (OECD TG 401, GLP) "Abdominal position, locomotor activity reduction, as for the fall of a posture and a locomotor activity, hind limb weakness, exhaustion of a hind foot, gait abnormality, etc., tend to recover. There is a description of "White hyperplasia part is observed in proventriculus mucosa."(the Health, Labor and Welfare Ministry reports (Access on September 2008), SIDS (2004))It has been described as "no effect" (SIDS (2004)) in the acute dermal administration test employing rabbits. Although the influence on the stomach in the oral administration test is seen within the range of the guidance value of Category 2, it was judged as a specific condition due to the forced oral administration and it is not adopted. As mentioned above, it was classified into Category 3 (Narcotic effects).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)	Warning	H373	P260 P314 P501	It is written in 28-day repeated oral administration test in rats (GLP) that"there were adiposis of periportal hepatocytes, increase in liver weight, and anemia tendency, however, the result showing abnormality of liver was not obtained by biochemical exam of blood (Ministry of Health, Labour and Welfare reports (Access on September 2008), SIDS (2004)), and "hemolytic anemia" was described in 13-week repeated oral administration test in rats (GLP) (SIDS (2004)), and effects on blood systems were found within the scope of the guidance value of Category 2. Therefore, it was classified into Category 2 (blood systems).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	It was classified into Category 1 from 96 hours LC50=0.028mg/L of the fish (Oryzias Latipes) (SIDS (2005)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since acute toxicity was Category 1 and there were no rapid degradability (not readily degradable, the decomposition by BOD: 2%(Existing Chemical Safety Inspections Data (1995))), it was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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