GHS Classification Result

Chemical Name:Di-o-tolylguanidine
CAS:97-39-2

Result:
ID: 22A4224
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement 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 - - - - 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 - - - - No data available.
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 applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
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 Not applicable - - - - Organic compounds containing no oxygen, fluorine or chlorine
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 Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
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 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)).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
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)).
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.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system) Danger H370: Causes damage to organs (central nervous system) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
9 Specific target organ toxicity - Repeated exposure Category 2 (central nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (central nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
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).
11 Hazardous to the aquatic environment (Long-term) 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)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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