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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	88-72-2
Chemical Name	2-Nitrotoluene
Substance ID	23B5525
Classification year (FY)	FY2011
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)	Physical Hazards & 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 (N-O) present in the molecule, but the classification is not possible due to no data.
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	Not classified	- -	-	-	A flash point of 95 deg C [closed-cup] (ICSC (J) (2000)) is above 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (N-O) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 420 deg C (HSDB (2009)).
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	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Among five LD50 values for rats [891 mg/kg and 2,100 mg/kg (the above, IARC 65 (1996)), 2,546 mg/kg, 1,610 mg/kg, and 890 mg/kg (the above, U-RAR (2008))], three correspond to Category 4, and two correspond to "Not classified." It was classified in Category 4 by adopting the category for more data.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Both an LD50 value for rabbits of > 20,000 mg/kg (EU-RAR (2008)) and an LD50 value for rats of > 5,000 mg/kg (EU-RAR (2008)) correspond to "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	There is a report on an LC50 value for rats of > 1.17 mg/L/1 hour (converted 4-hour equivalent value: 0.585 mg/L/4 hours, 104.5 ppm/4 hours) (EU-RAR (2008)), but because the category cannot be determined with this data alone, it was classified as "Classification not possible." Besides, because the test concentration (209 ppm) was lower than 90% of the saturated vapour pressure concentration (274 ppm), the reference value of gasses was applied as a vapour with little mist.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There is a report on an LC50 value for rats of > 1.795 mg/L/4 hours (> 320 ppm/4 hours) (EU-RAR (2008)), but because the category cannot be determined with this data alone, it was classified as "Classification not possible." Besides, because the test concentration (1.795 mg/L) was higher than the saturated vapour pressure concentration (1.39 mg/L), it was regarded as a test on mist.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was not irritating in both tests in which 0.5 mL of the undiluted test substance was applied to the rabbit skin for 4 or 24 hours (EU-RAR (2008)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was not irritating in both two tests in which 0.1 mL of the undiluted test substance was applied to the rabbit eye (EU-RAR (2008)). Besides, in one of the tests, scores for corneal opacity, iritis, conjunctival redness, and chemosis were 0 at all observation points in all the animals.
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	- -	-	-	It was negative in a micronucleus test with bone marrow after intraperitoneal administration to rats or mice (in vivo somatic cell mutagenicity test) (NTP TR504 (2002)), while multiple positive results were obtained in an unscheduled DNA synthesis test with hepatocytes after oral administration to rats (in vivo somatic cell genotoxicity test) and a DNA adduct formation test (in vivo somatic cell genotoxicity test) (NTP TR504 (2002), IARC 65 (1996)). It is questionable to classify it as "Not classified" from the negative result in the micronucleus test above, and there is no supporting information. Therefore, it was classified as "Classification not possible" due to lack of data. As for in vitro tests, it is reported that an Ames test was negative (NTP DB (1981)), a chromosomal aberration test with CHO cells was negative (NTP DB (1981), DFGMAK Doc.8 (1997)), and a chromosomal aberration test with CHL cells was negative (IARC 65 (1996)).
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B because IARC classified it in 2A for carcinogenicity (IARC News 101 (2011)). Besides, in 2-year diet administration tests with rats and mice, it was concluded that there was clear evidence of carcinogenicity in male and female rats because increased incidences of malignant mesothelioma, skin neoplasms, mammary gland fibroadenoma, and liver neoplasms were observed in male rats, and increased incidences of skin neoplasms and mammary gland fibroadenoma were found in female rats. On the other hand, it was concluded that there was clear evidence of carcinogenicity in male and female mice based on increased incidences of hemangiosarcoma, carcinoma of the large intestine (cecum), and hepatocellular neoplasms (females only) (NTP TR 504 (2002)). The EU classified it in Cat. 2; R45 (EC-JRC (ESIS) (Access on Sep. 2011)).
7	Reproductive toxicity	Classification not possible	- -	-	-	In a combined subchronic/reproductive toxicity test, decreased weight gain and food consumption and increased liver and kidney weight were observed at higher doses in parent animals. As for the reproductive system, a dosage-related decrease of epididymis, seminal vesicle, prostate, and testis weight was found at the same doses, but it is described that these effects were not considered enough evidence of impaired fertility in the absence of further details (EU-RAR (2008)). Therefore, it was classified as "Classification not possible." Besides, in a 13-week diet administration test with rats, degeneration of the testis with reductions in sperm count and motility in males and a prolongation of the menstrual cycle in females were seen at toxic doses of 5000 ppm (340-353 mg/kg/day) or above (EU-RAR (2008)).
8	Specific target organ toxicity - Single exposure	Category 2 (blood)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	Cases of poisoning from nitrotoluene are uncommon, it is considered only slightly toxic, especially in comparison with nitrobenzene, and it is considered low in methemoglobin forming potential, although the different isomers vary in somewhat toxicity (HSDB (2009)). Clinical signs of toxicity were seen 5-10 minutes after oral administration to rats, and an acceleration of the respiratory rhythm and convulsions mainly occurred with excitation, followed by a phase of slumber, which could be last 24 hours. A methemoglobin rate increased at 3,000 mg/kg, and death occurred at 1,500 mg/kg, and it is described that toxic signs were related to the formation of methemoglobin (EU-RAR (2008)). Because there was death within the guidance values for Category 2, it was classified in Category 2 (blood).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, blood)	Warning	H373	P260 P314 P501	In a 105-week diet administration test with rats, in the liver, there were significantly increased incidences of eosinophilic foci in males, and basophilic foci and clear cell foci in females at or above 0.0625% (25 mg/kg/day), cellular infiltration and centrilobular necrosis in males and eosinophilic foci in females at or above 0.125% (50 mg/kg/day), clear cell foci in males and mixed cell foci in females at 0.2% (90 mg/kg/day) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Therefore, it was classified in Category 2 (liver). Also, in the test, there is a report on hematopoietic cell proliferation in the spleen in males and females at or above 0.0625%, hyperplasia in the bone marrow in females at or above 0.125% (60 mg/kg/day), and pigmentation in the mediastinal lymph node and spleen in males and females at 0.2%. Fibrosis of the spleen capsule was reported at or above 89 mg/kg bw/day in a 13-week diet administration test with rats (DFGMAK Doc.8 (1997)), and changes in hematological parameters suggestive of anemia were reported after 30-day oral administration of 322 mg/kg/day to rats (EU-RAR (2008)). Therefore, it was classified in Category 2 (blood). Besides, in a 13-week diet administration test with rats, degeneration of the testis with reductions in sperm count and motility in males and a prolongation of the menstrual cycle in females were seen at toxic doses of 5000 ppm (340-353 mg/kg/day) or above (EU-RAR (2008)), but it was not adopted as evidence of the classification because the doses were above the guidance values for Category 2.
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)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 5.4 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), etc.).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	It was classified in Category 2 due to being not rapidly degradable (a 4-week degradation rate by BOD: 0.5% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and 21-day NOEC = 0.5 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008), etc.).
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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