NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	97-52-9
Chemical Name	4-Nitro-o-anisidine
Substance ID	24A6077
Classification year (FY)	FY2012
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data.
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	- -	-	-	There is information that it is combustible (GESTIS (Access on Aug. 2012)), but the classification is not possible due to no data in the prescribed test method.
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 360 deg C (MSDS (Sigma-Aldrich) (Access on Aug. 2012)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
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	In an acute toxicity test with rats (OECD TG 423), mortality was 0% (0/6) at 300 mg/kg and 100% (3/3) at 2,000 mg/kg, and the approximate lethal dose was estimated to be 500 mg/kg (JECDB (Access on Aug. 2012)), and there are descriptions of LD50 values of 997 mg/kg and 1,000 mg/kg for rats as quoted data (JECDB (Access on Aug. 2012)). Therefore, it was classified in Category 4.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, in vitro tests, there are reports on a positive result in an Ames test (JECDB (Access on Aug. 2012), NTP DB ID: G06049 (2008)) and a positive result in a chromosomal aberration test with Chinese hamster lung cells (CHL/IU) (JECDB (Access on Aug. 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a reproduction/developmental toxicity screening test with rats, there were no changes in estrus cycle, copulation index, fertility index, the number of corpus lutea, the number of implantations, implantation index, gestation index, and delivery and lactation condition of paternal and maternal animals, and as for the development of offspring, significantly decreased values in neonatal body weights were found in the 200 mg/kg group, but there were no changes in the number of pups born, delivery index, the number of live pups, live birth index, sex ratio, viability, body weights, and morphology (JECDB (Access on Aug. 2012)). Therefore, there were no adverse effects on sexual function/fertility, but data are insufficient on effects on the development of offspring including teratogenicity. Therefore, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 2 (systemic toxicity)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In an acute toxicity test with rats (OECD TG 423), at 300 mg/kg, there were no dead animals, and decreased locomotor activity, hypothermia, and yellow urine were observed. But the animals recovered and showed smooth weight gain, and no macroscopic changes were found at necropsy after the observation period. At 2000 mg/kg, decreased locomotor activity, prone position, hypothermia, yellow or yellowish-brown urine, and soiled perineal region from urine were observed, all six animals died, and hydrothorax and swelling of the adrenal gland were found in two out of three animals at necropsy (JECDB (Access on Aug. 2012)). From the above results, there were apparent toxicity effects within the guidance value range for Category 2, but the target organ could not be specified. Therefore, it was classified in Category 2 (systemic toxicity).
9	Specific target organ toxicity - Repeated exposure	Category 2 (haemal system, heart)	Warning	H373	P260 P314 P501	In a 28-day repeated oral administration toxicity test with rats (GLP-compliant), two females died in the 300 mg/kg group (converted guidance value: 93.3 mg/kg/day), and decreased locomotor activity at or above 100 mg/kg (converted guidance value: 31.1 mg/kg/day) and hypothermia at 300 mg/kg were observed. And the 300 mg/kg group showed lower values in hematocrit values, hemoglobin level, and erythrocyte counts and higher values in platelet counts and reticulocyte rate, and females in the 100 mg/kg group showed lower values in hematocrit values, and there were higher values in total cholesterol, GOT, GPT, and total bilirubin in the 300 mg/kg group. At the pathological examination, brown liver in males, hypertrophy and pallor of the heart, thickening of the heart sac, hydropericardium, and hydrothorax in females were observed in the 300 mg/kg group by macroscopic observation. As histological findings, there were myocardial damage and necrosis in the heart, and extramedullary hematopoiesis in the spleen in the 300 mg/kg group, and there were more pigment deposits in the spleen in females in the 300 mg/kg group than in the control group (JECDB (Access on Aug. 2012)). From the above results, it was classified in Category 2 (blood system) based on histological findings of extramedullary hematopoiesis and pigment deposits in the spleen in addition to lower values in hematocrit values, hemoglobin level and erythrocyte counts at 300 mg/kg (converted guidance value: 93.3 mg/kg/day) corresponding to the guidance values for Category 2. And it was classified in Category 2 (heart) based on histological findings of myocardial damage and necrosis in addition to macroscopic findings such as hypertrophy and pallor of the heart, thickening of the heart sac, and hydropericardium.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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