NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	89-63-4
Chemical Name	4-Chloro-2-nitroaniline
Substance ID	m-nite-89-63-4_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	- -	-	-	There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Division 6.1, PGIII in UNRTDG (UN 2237), it does not correspond to explosives, hazard class with the highest precedence.	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	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Division 6.1, PGIII in UNRTDG (UN 2237), it does not correspond to self-reactive substances and mixtures, hazard class with the highest precedence.	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 518 deg C (GESTIS (Access on June 2016)).	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	Classification not possible	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (P). However, the classification is not possible due to no data.	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	There are two reports of LD50 values of 400 mg kg (HSDB (Access on June 2017)), >5,000 mg/kg (BUA 235 (2002)) for rats, one corresponds to Category 4, and the other corresponds to "Not classified." There is a report of an LD50 value of 800 mg/kg (HSDB (Access on June 2017)) for mice, and it corresponds to Category 4. The category with more cases was adopted, and it was classified in Category 4. The classification was reviewed based on the information obtained in this survey.	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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	There is a report that it was not irritating in a skin irritation test with rabbits (BUA 235 (2002)), but for humans, there are reports that it caused moderate to severe erythema (redness) and moderate edema (HSDB (Access on June 2017)). From the above, it was classified in Category 2. The classification was reviewed based on the information obtained in this survey.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Based on a report that it caused temporary yellowing of the sclera or partially of the cornea in an eye irritation test with rabbits (according to FDA guideline), however, it was not irritating to the conjunctiva (BUA 235 (2002)), it was classified as "Not classified."	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	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, in a skin sensitization test with guinea pigs, there is a report that 4 out of 4 animals showed a positive reaction (BUA 235 (2002)), but it was not adopted because details of the testing method and the test result were unknown.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. Besides, as for in vivo, it was negative in a micronucleus test using mouse bone marrow cells (BUA 235 (2002)), and as for in vitro, it was positive in a bacterial reverse mutation test, and a mouse lymphoma test, a chromosome aberration test, and a sister chromatid exchange test with mammalian cultured cells (JECDB (Access on June 2017), NTP DB (Access on June 2017), BUA 235 (2002)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Not classified	- -	-	-	In a carcinogenicity study with rats and mice dosed by feeding, no increase in tumor incidence was observed in both sexes of rats and mice (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on June 2017)). There was no classification result by other organization, but the negative results of carcinogenicity were seen in two species of experimental animals. Therefore, it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), no reproductive/developmental effect was observed at up to 300 mg/kg/day at which effects on the blood and spleen, etc. were noticed (Safety Test (Ministry of Economy, Trade and Industry (METI)) (Access on June 2017)). However, it is impossible to classify it as "Not classified" with only this result since this test is a screening test, and there are no other available data. 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	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no information on single exposure of this substance in humans. For experimental animals, there is a description that deep narcosis lasted for 24 hours after a single non-lethal oral administration of this substance to guinea pigs in results from a test conducted in 1935 (BUA 235 (2002)), however, since the details are unknown and the original literature is also unavailable and cannot be confirmed, it was not adopted as evidence of classification. Though there is a report that temporal prone position, yellow skin and yellow urine were noted in rats (BUA 235 (2002)), it is impossible to identify the target organs with this information alone. Therefore, it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)	Warning	H373	P260 P314 P501	No information on humans is available. As for experimental animals, in a 13-week repeated oral dose toxicity study with rats dosed by feeding, increased liver weights and increases in total cholesterol, phospholipid, and albumin were shown at or above 640 ppm (male: 38 mg/kg/day, female: 44 mg/kg/day) which is within the guidance value range for Category 2, and a decrease in hemoglobin concentration, an increase in a reticulocyte ratio, an increase in total bilirubin and total protein were found at or above 1600 ppm (male: 94 mg/kg/day, female: 106 mg/kg/day) which is near the upper limit of the guidance value range for Category 2. In a two-year repeated dose toxicity study with rats dosed by feeding, males at or above 1400 ppm (65 mg/kg/day) which is within the guidance value range for Category 2 showed decreases in erythrocyte count, hemoglobin concentration, hematocrit value, increases in total cholesterol, triglyceride, phospholipid, blood urea nitrogen, creatinine, calcium, inorganic phosphorus, a granular change of the kidney, increases in absolute and relative weights of the lung, liver, and kidney, chronic nephropathy, urothelial hyperplasia of the renal pelvis, etc., and females at 800 ppm (46 mg/kg/day) or more showed increases in platelet count, calcium, increased relative weight of the liver, chronic nephropathy, etc. (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on June 2017)). In addition, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), there is a report of a decreased hematocrit value and extramedullary hematopoiesis in the spleen (Safety Test (Ministry of Economy, Trade and Industry (METI)) (Access on June 2017)). Besides this, it is reported in a 13-week repeated oral dose toxicity study with rats and mice given by gavage that in rats, hemosiderosis of the spleen and increased liver weight at or above 50 mg/kg/day which is within the guidance value range for Category 2, and eosinophilic hyaline droplets and regeneration of the renal proximal tubule, which are specific to male rats, at or above 100 mg/kg/day were observed, and in mice, hemosiderosis in the spleen was noted at 75 mg/kg/day which is within the guidance value for Category 2 (BUA 235 (2002)). From the above, within the guidance value range for Category 2, effects on the haemal system, findings accompanying the effects on the haemal system, effects on the kidney (findings specific to male rats, chronic nephropathy seen in males and females in the 2-year study) were observed, but the kidney was not adopted as the target organ because of the finding specific to male rats and the age-related change. Therefore, it was classified in Category 2 (haemal system).	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 2	- -	H401	P273 P501	From 48-hour LC50 = 4.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0%) (J-CHECK: 1977), and 72-hour NOEC (rate method) = 2.1 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0%) (J-CHECK: 1977), and 48-hour EC50 = 4.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). From the above results, it was classified in Category 2.	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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