NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	97-39-2
Chemical Name	Di-o-tolylguanidine
Substance ID	m-nite-97-39-2_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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Based on the rat LD50 values of 85.3 mg/kg (male) and 56.0 mg/kg (female) (OECD TG401, GLP-compliant) ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2003)), the substance was classified into Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented case of "not irritating" resulted from the Draize test (12 animals, 24 hours) using rabbit (SIDS (2007)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the Draize test (6 animals, 24 hours) using rabbits, 24-hour application of the substance caused slight damage to the cornea (3 of 6 animals), mild iritis (4 of 6 animals), and mild to moderate conjunctivitis (all of 6 animals) were observed. The mild conjunctivitis was still present in half of the rabbits after 7 days (SIDS (2007)). Therefore, the substance was classified as Category 2A.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	Insufficient data were available. No sensitizing effects were reported in three human sensitization studies, but methods of exposure were unclear and the information was judged as insufficient to evaluate in SIDS (SIDS (2007)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified as "Not classified" based on the negative results in the micronucleus test using mice orally administered (in vivo mutagenicity test in somatic cells) (OECD TG474, GLP-compliant) (SIDS (2007)). As relevant information, as for in vitro studies, positive results in the chromosome aberration test ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Dec. 2010)) and negative results in the Ames test ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Dec. 2010), SIDS (2007)) were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the reproduction/developmental toxicity screening test in rats, in which males were orally dosed from 14 days before mating, and 35 days including the mating period, females were orally dosed from 14 days before mating throughout the mating and pregnancy period to day 3 of lactation, decrease in the numbers of newborns and live newborns and birth index and viability index on day 4 of lactation, and increase in the incidence of pups with external malformations were observed at the dose levels that induce general toxicity such as deaths, salivation, mydriasis, decreased locomotor activity in parental animals ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2003)). In the developmental toxicity test in which rats were orally administered with test substance on days 6 - 19 of pregnancy, significant increase in the number and incidence of embryonic/fetal deaths, dose-dependent incidence of pups with external malformations, skeletal anomalies such as absence, fusion or malposition of caudal vertebrae were observed at the dose levels that induce decreased body weight gain and food consumption in parental animals ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (2004)). The results mentioned above indicate the adverse effects on the development of the offspring at the dose levels that induce general toxicity in parental animals. Therefore, the substance was classified as Category 2.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In the acute oral toxicity study in rats (OECD TG401, GLP-compliant), deaths occurred within 30 - 45 minutes after dosing in the groups at 60 mg/kg or more, and signs such as mydriasis, decrease in locomotor activity, bradypnea or tremors were observed in the decedents and in the survivors at 30 mg/kg/or more, but all of the signs in the survivors disappeared on the following day ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2003)). In another acute oral toxicity study in rats administered at 103-216 mg/kg bw, deaths occurred within 21 hours, and clinical signs observed included inanimation, tremor, and convulsions, but the signs disappeared in the survivors during the observation period (SIDS (2007)). In consideration of the time course of toxic signs described above, the target organ seemed to be central nervous system and the effects were observed at the dose levels equivalent to Category 1 of the guidance values. Thus, the substance was classified as Category 1 (central nervous system). In addition, no pathological changes were noted in the survivors in the above studies.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system)	Warning	H373	P260 P314 P501	In the reproduction/developmental oral toxicity screening test in rats (dose levels: 8, 20 and 50 mg/kg/day, converted values as that of 90-day study: approx. 4, 10 and 25 mg/kg/day), it was reported that the signs indicating the effects on central nervous system such as mydriasis, clonic convulsion and tremor were frequently observed after administration during early phase in the groups at 50 mg/kg (converted values as that of 90-day study: approx. 25 mg/kg) for both sexes, and that two each of both sexes died until administration day 7 ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2003)). In the 28-day repeated dose oral toxicity study in rats (dose levels: 0, 7.5, 15, 30 and 60 mg/kg, converted values as that of 90-day study: 2.5, 5, 10 and 20 mg/kg), it was also reported that the signs containing tremors, decreased locomotor activity, bradypnea, and decreases in pupillary reflexes, decreases in arousal situation and decreases in visual reaction were observed in the groups at 60 mg/kg (converted values as that of 90-day study: 20 mg/kg) for both sexes ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2003)). Based on the information, the substance was classified as Category 2 (central nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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	Classified into Category 2 from its 48h-EC50 = 7.2 mg/L for crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2002).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since its long-term toxicity data is > 1 mg/L (21d-NOEC = 2.8 mg/L for crustacea (Daphnia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2002) though its acute toxicity is Category 2 and it is not rapidly degradable (Non-biodegradable, BOD degradation rate: 0 - 1% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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