NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	95-49-8
Chemical Name	o-Chlorotoluene
Substance ID	H26-B-026, R-010
Classification year (FY)	FY2014
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	FY2006
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)
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 3 based on a flash point of 43 deg C (closed cup) (ICSC (2003)). Besides, it is classified in Class 3, PG III (UN2238) in UNRTDG.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 550 deg C (GESTIS (Access on July 2014)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	There are reports of LD50 values of >1,600 mg/kg (ACGIH (7th, 2001)), 3,227 mg/kg (male), 3,860 mg/kg (female) (SIDS (2004)), 3,900 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)), 3,227-3,464 (male) and 3,031-3,860 (female) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)) for rats. It was classified as "Not classified" (Category 5 in UN GHS classification) to which the larger number of data corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on reports of an LD50 value of >1,083 mg/kg for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)) and an LD50 value of >2,165 mg/kg for rabbits (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)), it was classified as "Not classified." New information sources (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)) were added, and the classification was revised.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on an LC50 value (4 hours) of 37.51 mg/L for rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)), it was classified as "Not classified." Besides, since the LC50 value was higher than the saturated vapor concentration (17.8 mg/L), the reference value as a mist was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a skin irritation test (OECD TG 404) with rabbits, erythema was observed after 4-hour application but disappeared later (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Besides, in multiple tests in which this substance was applied for 24 hours, although moderate edema, severe erythema and necrosis, etc. were observed, and moderate desquamation, thickening at the application site, exfoliation and scarring were observed 1 week after administration (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), it was judged to be mild irritation in the OECD-compliant test, therefore, it was classified as "Not classified" (Category 3 in UN GHS classification). The category was changed according to the revised guideline.
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	There is a report that in an eye irritation test (OECD TG 405) with rabbits, symptoms such as hyperemia of the conjunctival blood vessels and slight edema were observed by administration of this substance, but all these disappeared within 7 days (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, in other multiple eye irritation tests with rabbits, it was judged to be slightly irritating to the eyes (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was classified in Category 2B.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	There is a report that no skin sensitization was observed in a maximization test (OECD TG406) with guinea pigs (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). In addition, there is a report that it was negative in another sensitization test with guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above results, it was classified as "Not classified."
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. As for in vivo, it was negative in a chromosomal aberration test with rat bone marrow cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). As for in vitro, it was negative in bacterial reverse mutation tests, and a mouse lymphoma test and a chromosomal aberration test with cultured mammalian cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	There is a report that in a teratogenicity test with rats by the inhalation route, effects on the fetal development (significantly reduced fetal weight, brachydactyly) were observed at a dose (9,000 mg/m3) where maternal toxicities (decreased body weight gain, slight to moderate ataxia) were observed (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). However, as for this study, the Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) and SIDS (2004) regarded a malformation, brachymelia (in 1 out of 126 pups from 22 maternal animals)observed at only the dose (1,100 mg/m3) where no maternal toxicity was observed, as a significant change, although there was no clear dose dependence. In this classification, since occurrence frequency of brachymelia observed at 1,100 mg/m3 was small and it was not observed at the middle dose, it was judged to be unclear, therefore, significant decrease of fetal body weight and brachydactyly at the dose (9,000 mg/m3) where material toxicity was observed were judged to be the effects. In addition, there is a report that in a teratogenicity test with rabbits by the inhalation route, maternal toxicity was observed but not fetotoxicity (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). Also, about this, Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) and SIDS (2004) regarded a malformation of brachymelia (1 out of 77 pups from 10 maternal animals) observed at the dose (10,000 mg/m3) where deaths (4/16 animals) were observed in maternal animals, as a significant change. However, in this classification, this finding observed in rabbits was not adopted as evidence of the classification since severe effects including deaths were observed in maternal animals. As in the above, since the congenital malformation (brachydactyly) described in the previous classification was observed at the extremely high dose, the dose where general toxicity was manifested in maternal animals, it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	This substance was irritating to the respiratory tract (Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005)). As for experimental animals, by inhalation exposure to rats, it showed respiratory tract irritation at 72.5 mg/L, and hypoactivity, dyspnea, abdominal respiration, exudation from the eyes and nose, tremors and prostration at 36.9 mg/L. By inhalation exposure, rats showed an uneven coloration on the surface of the lungs and liver and foci of red and black discoloration on the surface of the lungs at necropsy (SIDS (2004), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), loss of coordination, prostration, tremors and vasodilation at 20.7 mg/L (ACGIH (7th, 2001)), and labored breathing and anesthesia at 72.5 mg/L (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), and mice showed decreased respiratory rate at 2.7-5.2 mg/L (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). By oral administration, rats showed dyspnea and sedation, and atrophy of the liver and focal inflammation in the gastric mucosa at necropsy at or above 1,000 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), difficulties in breathing and sedation at 3,227-3,860 mg/kg (SIDS (2004)), and vasodilation at 50-1,600 mg/kg (ACGIH (7th, 2001)), and dyspnea was observed at 1,083 mg/kg after dermal application to rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2004)). The above findings in the lungs and liver were considered to be secondary effects. The applied concentrations by inhalation exposure in rats exceeded the guidance value range corresponding to Category 2. Based on the findings by inhalation exposure with mice, oral administration to rats, and dermal application, it was judged as reasonable to regard them as narcotic effects. From the above, it was classified in Category 3 (respiratory tract irritation, narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system)	Warning	H373	P260 P314 P501	Regarding reports on occupational exposures in humans, there is no toxicity information regarded as reliable in each assessment report and available for classification (ACGIH (7th, 2001), SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). As for experimental animals, in a 104-day feeding test with rats, although NOAEL of 20 mg/kg/day with decreased body weight gain as an indicator was set (IRIS (1990), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), no clear target organ toxicity was observed within or lower than the dose range of Category 2, and also in a test in which dogs were administered by gavage for 97 days, no clear target organ toxicity was observed at up to 80 mg/kg within the range of Category 2 (IRIS (1990), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Therefore, no data were available for classification by the oral route. On the other hand, by the inhalation route, in a 14-day inhalation exposure test with rats, central nervous depression and an increase in liver and kidney weights were observed at the concentration (4.0 mg/L; 0.62 mg/L (converted guidance value)) corresponding to Category 2. As pathological findings in the liver and kidney, only centrilobular hepatocyte enlargement was observed in the group of 15.3 mg/L (converted guidance value: 2.38 mg/L) of the highest concentration (SIDS (2004), Environmental Risk Assessment for Chemical Substances Vol.4 (Ministry of the Environment, 2005), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), therefore, the liver and kidney were excluded from target organs. From the above, it was classified in Category 2 (central nervous system). Besides, the previous classification was conducted based on the information sources in List 3, and this time, the classification result was different since it was classified from the information sources in List 1.
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	It was classified in Category 1 from 48-hour EC50 = 0.70 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. 4 (Ministry of the Environment, 2005), Initial Risk Assessment (NITE, CERI, NEDO, 2008)).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1979)), and 21-day NOEC = 0.08 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2008), SIDS, 2001).
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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