NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	95-51-2
Chemical Name	o-Chloroaniline
Substance ID	m-nite-95-51-2_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	Based on a flash point of 108 degC (ICSC (2000)), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is haloaniline as a chemical group associated with self-reactive properties present in the molecule. However, because it is classified in Division 6.1 (Toxic substances), Packing group II (UN2019, chloroanilines, liquid) in UNRTDG, it is thought that it does not correspond to self-reactive substances and mixtures which is hazard class with the highest precedence.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an ignition point of >500 deg C (ICSC (2000)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	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 liquid substances are not available.	FY2016	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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	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	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	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	On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	Five LC50 values (4 hours) for rats of 4,000 - 6,000 mg/m3 (PATTY (6th, 2012)), 4,160 mg/m3 (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)), 4,100 mg/m3, 6,000 mg/m3, and > 4,406 mg/m3 (BUA 57 (1991)) are reported, and these values correspond to Category 4 to "Not classified." By adopting the category with higher hazard, the substance was classified in Category 4. Besides, the reference value of mist was applied because the LC50 values are higher than the saturated vapor pressure concentration (1.17 mg/L).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test using rabbits (OECD TG 404), there is a report that application of 0.1 mL of this substance resulted in no irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). Therefore, it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported that in an eye irritation test (OECD TG 405) using rabbits, after applying 0.1 mL of this substance to the conjunctival sac, conjunctival hyperemia and corneal opacity were observed, but resolved within 3 – 7 days (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). From the above, this substance was classified in Category 2B.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Negative result is reported in a maximization test using guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). However, this substance was classified as "Classification not possible" because details of the test conditions and results are unknown.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, one weak positive result was observed in a mouse micronucleus test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), however, it is described micronucleus tests using bone marrow cells or peripheral blood of mice (including the data without the description of examinaton site) were all negative according to another information sources (NTP TOX43 (1998), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol. 21 (2003)). A positive result in a micronucleus test using bone marrow cells of rats was observed (NTP TOX43 (1998)). But as for the positive result of the micronucleus test in bone marrow cell of rats, its reproducibility is not confirmed, therefore it is difficult to judge definitely to be positive (NTP TOX43 (1998)). As for in vitro, results are a negative in a bacterial reverse mutation test, positive in a mouse lymphoma test and a gene mutation test using mammalian cultured cells, a positive or a negative in a chromosome aberration test and a sister chromatid exchange test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), NTP TOX43 (1998), DFGOT vol. 21 (2003)). From the above, there are positive in vitro results, but the positive in vivo result was difficult to judge clearly as the positive one. Therefore, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government, although the former classification was Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the reproduction/development toxicity screening test using pregnant rats given this substance by gavage administration on an organogenesis period, in maternal animals, effects on spleen (weight gain, hyperemia, increased extramedullary hematopoiesis) and necrosis of the placental membrane at or above 50 mg/kg/day, tremors, reduced body weight gain, decreased food consumption at 250 mg/kg/day were observed, and in fetuses, increased embryo absorption, decreased survival rate, increased spontaneous malformations (details unknown) at 250 mg/kg/day were observed (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Besides, because fetotoxicity and spontaneous malformations were observed at the dose with apparent maternal toxicity, the substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (blood system), Category 2 (central nervous system, heart)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	In humans, there is a report methemoglobin is formed by acute exposure to this substance (PATTY (6th, 2012)). As effects on the central nervous system, occurrences of confusion, ataxia, vertigo, tinnitus, disorientation, weakness, lethargy, and coma are noted; and as effects on the heart, heart blocks, arrhythmias, and shock are noted (HSDB, Access on October 2016). In experimental animals, cyanosis, dyspnea, muscle weakness, coma, tremor, spasm and so on are observed due to the formed methemoglobin in oral, inhalation and dermal administration tests using rats and mice at dose equivalent to Category 1 or 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), DFGOT vol. 3 (1990), BUA 57 (1991)). From the above, this substance was classified in Category 1 (haemal system), Category 2 (central nervous system, heart). Because HSDB is the source of information on humans, is on List 2, the substance was classified in Category 2 for the central nervous system and heart. The liver and kidney were target organs in the previous classification. Upon checking the original literature of its classification rationale, which is cited in Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), the effects on the liver and kidney in humans are not described in it. Therefore, the category was changed.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system, central nervous system)	Danger	H372	P260 P264 P270 P314 P501	In humans, though epidemiological studies and cases involving exposure only to this substance have not been obtained, symptoms such as cyanosis and anemia are reported in factory employees exposed to nitro compounds and amino compounds including this substance. Between 1961 – 1980 in UK, cyanosis in 325 factory employees exposed to nitro compounds or amino compounds were reported. It is presumed that this was caused by chloroaniline (details unknown regarding isomers) in not less than 60 people. Headache, fatigue, dizziness and nausea occurred in 87% of the cases during the exposure period, and were observed in 13% of the cases even after exposure. In addition, from 1956 to 1965 in US, cyanosis and anemia were observed in 187 factory employees exposed to not less than 20 kinds of nitro compounds and amino compounds including m- chloroaniline and this substance. It is presumed this was mainly caused by dermal absorption (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). 　In experimental animal, in a 4-week (6hr/day, 5days/week) inhalation toxicity test using rats, decreased hematocrit values, increased Heinz body and methemoglobin concentration, increased spleen weight and so on were observed at or above 7.37 ppm (converted guidance value: 0.008 mg/L), which corresponds to Category 1. Cyanosis, decreased hemoglobin concentration, increased reticulocytes, hemosiderin deposition in the spleen and so on were observed at or above 41.0 ppm (0.048 mg/L). Tremors etc. were confirmed at 167.5 ppm (converted guidance value: 0.197 mg/L) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In 13-week repeated-dose toxicity tests in rats or mice by the oral route, increased methemoglobin concentration is also observed at 10 mg/kg/day (converted guidance value: 7.4 mg/kg/day), which corresponds to Category 1. Cyanosis, tremors, increased hematopoiesis in the spleen, etc. were observed at doses corresponding to Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), NTP TOX43 (1998), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). Therefore, this substance was classified in Category 1 (haemal system, central nervous system).	FY2016	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. Besides, kinematic viscosity is calculated to be 2.407 mm2/sec (20/22 degC) from the numerical data (viscosity: 2.9157 mPa*s (20 degC), density (specific gravity): 1.2114 (22/4 degC)) listed on HSDB (Access on September 2016).	FY2016	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 1	Warning	H400	P273 P391 P501	From 48-hour LC50 = 0.13 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Because it is not rapidly degradable (BOD degradability: 2.7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and its 21-day NOEC (reproduction) is 0.032 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2000), Environmental Risk Assessment for Chemical Substances vol. 2 (2003), vol. 3 (2004) and vol.9 (2011) (Ministry of the Environment), Initial Risk Assessment (NITE, CERI, NEDO, 2005), ECETOC TR91 (2003)), it was classified in Category 1.	FY2016	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.	FY2016	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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