GHS Classification Result

Chemical Name:1,3-Diphenylguanidine
CAS:102-06-7

Result:
ID: 1-205
Classifier: Ministry of Economy, Trade and Industry (METI), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

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 molecules.
2 Flammable gases (including chemically unstable gases) Not applicable - - - - Solid
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Solid
5 Gases under pressure Not applicable - - - - Solid
6 Flammable liquids Not applicable - - - - Solid
7 Flammable solids Classification not possible - - - - Classification not possible due to lack of data
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups associated with explosive or self-reactive properties present in the molecule.
9 Pyrophoric liquids Not applicable - - - - Solid
10 Pyrophoric solids Classification not possible - - - - Classification not possible due to lack of data
11 Self-heating substances and mixtures Classification not possible - - - - Classification not possible due to lack of data
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.
13 Oxidizing liquids Not applicable - - - - Solid
14 Oxidizing solids Not applicable - - - - It is an organic compound not containing oxygen, fluorine or chlorine.
15 Organic peroxides Not applicable - - - - The organic compound not including peroxy group in molecule.
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 ...
From LD50 value 107 mg/kg (Health, Labor and Welfare Ministry report (Access on September 2008)) of the acute oral toxicity test (OECD TG 401, GLP) employing a rat, it was classified into "Category 3". in EU classification, iXn; R 22 (EU-Annex I) is equivalent to Category 3-4.
1 Acute toxicity (Dermal) Not classified - - - - It was classified into "Not classified" from LD50 value >2,000 mg/kg (SIDS (draft, 2002)) of the dermal administration test employing a rabbit (Directive 92/69/EEC, B.3, GLP).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - Classification not possible due to lack of data
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - Classification not possible due to lack of data
2 Skin corrosion/irritation Not classified - - - - There is a description , "PII:0, no skin irritation,"(SIDS (drft,2002)) in the 24 hour skin irritation test (Draize Test) with rabbits. In addition, there is a description, "There is no skin irritation, " with regard to the effects on humans (HSDB (2005)). It was classified into "Not classified" based on the above-mentioned. EU division Xi:R38 (EU-Annex) corresponds to Category 2.
3 Serious eye damage/eye irritation Category 2 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.
From the description that it is PII:20 (maximum: 110) in case of 20mg application and it recovers in 7days and it is PII:48 (maximum: 110) in case of 100 mg application and it recovers in 21 days in the eye irritation test (Draize Test) employing rabbits (SIDS (draft, 2002)), it was classified into Category 2. EU classification is Xi; R36 (EU-Annex I) and is equivalent to Category 2.
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - For humans, there are some examples of sporadic positive reaction in the patch test mainly to gum contact dermatitis patients (SIDS (draft, 2002)). On the other hand, for animals, it has been described that "human positive data are guessed to result from not direct effects of the substance but from cross reaction" (SIDS (draft, 2002)) since it shows negative in the Maximization tests with guinea pig (OECD TG 406, GLP). It has been summarized in recent literature (Contact Derm.54 (2006)) that although 4 of 5 users of the surgical gloves comprising the substance were positive in the human patch test, a conclusion cannot be drawn because of few subjects. Therefore, classification is not possible.
5 Germ cell mutagenicity Not classified - - - - It was classified into "Not classified" based on a statement that the chromosome aberration test employing the rat bone marrow cells from the body cell in vivo mutagenicity test (OECD TG475, GLP) was negative (SIDS-draft (2002)). In addition, the 13-week mixed-feed-administration micronucleus tests which employed peripheral blood of mice showed male: negative and female: non-determinable (NTP DB (Access on September 2008)). As for in vitro examinations, the reverse mutation tests which employed bacterial cells was slightly positive (NTP DB (Access on January2009)), the mutagenicity test using bacterial cells (OECD TG471, GLP) was negative, and the chromosome aberration test using negative and a Chinese hamster cultured cell (OECD TG473, GLP) was negative (Health, Labor and Welfare Ministry reports (Access on September 2008)).
6 Carcinogenicity Classification not possible - - - - There is a description that tumor is not seen in a 32-week and 21-month mixed-feed-administration examination employing mice, but this is an insufficient data to determine carcinogenicityity (SIDS (draft, 2002)), and no evaluation by major international evaluation agencies is done, therefore, classification is not possible.
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 an oral administration study in 6-15 day pregnant rats (EPA Health Effects TG 560/6-82-001, GLP) it is reported that decreased fetal weight, increases in the loss of postimplantation embryos and retarded ossification were observed at doses at which decreased weight gain was observed in mother animals (SIDS (draft, 2002)), so it was classified as Category 2. The EU classification is Cat. 3; R62 (EU-Annex I), and it is equivalent to Category 2 in GHS.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects) Warning H336: May cause drowsiness or dizziness (narcotic effects) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ...
Although liver (darkening) is described in the oral administration employing rats (SIDS (draft, 2002)), it does not fall under significant clinical findings and thus it is not adopted. Moreover, although there is a description of "The workers have the condition of mucosal irritation, the stomach or the gallbladder and liver metabolic inhibition in working environment."(SIDS (draft, 2002)), since it is estimated as "a research with scant corroboration performed in early stage", this is not adopted. On the other hand, there is a description of "Locomotor activity reduction and decubitus position or gait abnormality were observed immediately after administration in all treated groups" in the acute oral toxicity test employing rats where the lethal dose was found (OECD TG 401, GLP) (Health, Labor and Welfare Ministry reports (Access on March 2008)), thus, it was classified into Category 3 (Narcotic effects). The EU classification is Xi; R36/37/38 (EU-Annex I).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - It is written in 90-day repeated oral administration test in rats (OECG TG408, GLP) that there were no primary effects on organs, and control of increased weight by the dosage within the scope of the guidance value of Category 2 and difference from control group in the blood test, the clinical chemical test, and the urine test by the dosage out of the scope of the guidance value of Category 2 are due to feed intake reduction based on decrease in eating quality of this substance (SIDS (draft, 2002)). Control of increased weight or feed intake reduction corresponds to (a) described in the GHS U.N. documents 3.9.2.8 (slight changes in increased weight amount and feed intake amount that does not show "serious" toxicity by only itself ), and is considered to be effects that do not support the GHS classification. Therefore, classification is not possible since data is insufficient.
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

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 ...
It was classified into Category 2 from 72 hours ErC50=7.6mg/L of the algae (Pseudokirchneriella subcapitata) (Environmental Agency eco-toxicity tests of chemicals (1998)).
11 Hazardous to the aquatic environment (Long-term) Category 2 - H411: Toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ...
Since acute toxicity was Category 2 and there were no rapid degradability (not readily degradable, the decomposition by BOD(standard test method (2 weeks)): 0% (Existing Chemical Safety Inspections Data (1977)), it was classified into Category 2.


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

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Model SDS by MHLW

MHLW Website (in Japanese Only)


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