GHS Classification Result

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

Result:
ID: 9
Classifier: Ministry of Economy, Trade and Industry (METI)
Year Classified: FY2007
Reference Manual: GHS Classification Manual (10 Feb, 2006)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives - - - - - -
2 Flammable gases (including chemically unstable gases) - - - - - -
3 Aerosols - - - - - -
4 Oxidizing gases - - - - - -
5 Gases under pressure - - - - - -
6 Flammable liquids - - - - - -
7 Flammable solids - - - - - -
8 Self-reactive substances and mixtures - - - - - -
9 Pyrophoric liquids - - - - - -
10 Pyrophoric solids - - - - - -
11 Self-heating substances and mixtures - - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - - -
13 Oxidizing liquids - - - - - -
14 Oxidizing solids - - - - - -
15 Organic peroxides - - - - - -
16 Corrosive to metals - - - - - -

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 ...
It classified into Category 3 from LD50 value 107 mg/kg (Health, Labor and Welfare Ministry reports (Access on Mar.2008)) of the oral administration test employing a rat. EU-Annex I is R22 and is equivalent to Category 3-4.
1 Acute toxicity (Dermal) Classification not possible - - - - Due to insufficient data, classification is not possible. In the dermal administration test by the GLP compliance employing rabbits, mortality cannot be found, even if a dose is 2,000 mg/kg (IUCLID (2000)). Therefore, although it was not classified into Category 4, suitability of Category 5 cannot be judged.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Since it was a solid by the definition of GHS, 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 - - - - It was classified into "Not classified" with no skin irritation in human (HSDB (2005)) and with no irritation with primary irritation index: 0 (up to 8.0) in a 24-hour blockade Draize test with rabbits (IUCLID (2000), SIDS-DRAFT (2002)). It has been described that the data in rabbits are reliable with restriction (SIDS-DRAFT (2002)). EU-Annex I is R38, and it is equivalent to Category 2.
3 Serious eye damage/eye irritation Category 2B - Warning H320: Causes 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.
From descriptions that it has eye irritation in humans (HSDB (2005)), it has mild eye irritation (ICSC (2000)), it has eye irritation in Primary irritation index:20-48 (maximum: 110) of test employing rabbits and the Draize test employing rabbits (it recovers in 48 hours) (IUCLID (2000)), it was classified into Category 2B. In addition, EU Annex I is R36 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 - - - - It has been listed in the Japanese Society for Contact Dermatitis (Japanese Society for Contact Dermatitis HP (2008)), and data showing positive reaction in 2 (of 49) in the human patch test and those showing sporadical positive reaction in rubber contact dermatitis patients have been described in IUCLID (2000) and HSDB (2005). In addition, according to the Japanese Society for Contact Dermatitis HP (2008), although positive reaction examples have been indicated in the human patch test, examples confirmed as a cause chemical has not been reported yet. In SIDS-DRAFT (2002), human data of IUCLID (2000) and HSDB (2005), etc. is indicated, and also the negative result of maximization test using guinea pig by OECD Guideline (reliability: valid without restriction), and it is concluded that it is inferred that human positive reaction is not a direct reaction of the substance but a cross-reactivity. In the recent literature (Contact Dermatitis, 54, 61-62, 2006), it is summarized that a conclusion cannot be drawn due to lack of subjects though four of the five subjects using surgical gloves, including this substance, were positive in the human patch test. From the above, it was considered that it could not be classified.
5 Germ cell mutagenicity Not classified - - - - Since the defined positive reaction has not been obtained in the micronucleus test employing mouse peripheral blood (male: negative, female: judgment is impossible) (NTP DB (Access on Jan.2008)), it is slightly positive (NTP DB (Access on Jan.2008)) or negative (Access on Mar. 2008)) in the in vitro reverse mutation test employing bacteria, and it is negative in the chromosome aberration test using a culture cell (Health, Labor and Welfare Ministry reports (Access on Mar. 2008)), based on the weight of evidence, it is classified into "Not classified".
6 Carcinogenicity Classification not possible - - - - A tumor is not seen in the 32-week oral administration test employing mice (IUCLID (2000)), however, the study period was short and there was no existing classification of IARC or others, therefore it was presupposed that 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 ...
Since fetal toxicity (decrease in fetal body weight and increase in the number of lost embryos after implantation) are observed at the dose level where maternal toxicity (body weight decrease and suppression of body weight increase) are observed in the reproductive toxicity study via forced oral administration using pregnant rats (SIDS-DRAFT (2002), IUCLID (2000), HSDB (2005)), it was classified in Category 2. EU-Annex I is Cat. 3; R62, corresponding to GHS Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - Although there is a description of darkening of liver in the oral administration test employing rats (SIDS-DRAFT (2002)), it corresponds to (a) (clinical finding of not showing the "serious" toxicity by only the fact) given in U.N. GHS document 3.8.2.1.8 and is considered the effect which does not support GHS classification. Therefore, it was classified into "Classification not possible" due to insufficient data. In addition, the data of the rat given in SIDS-DRAFT (2002) has been considered as reliable with restriction. EU-Annex I is Xi; R36/37/38, and is equivalent to Respiratory tract irritation.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 90-day repeated oral administration test in rats, decreased weight gains and decrease in feed intake were found by the amount of administration of 32 mg/kg/day, and in 90-day repeated oral administration test in mice, decreased weight gains were found by the amount of administration of 114 mg/kg/day, however, effects on organs, hematological and clinical symptoms, and urine test, etc. are not found (SIDS-DRAFT (2002)). The control of weight gain and the reduction of food intake correspond to (a) described in UN documents 3.9.2.8 on GHS (weight gain and subtle changes of food intake which themselves do not indicate any "significant" toxicity), and these are considered to be effects not supporting GHS classification. Therefore, it was defined as Classification not possible due to the lack of data. In addition, the above data on the rats and mice is indicated as valid without restriction (SIDS-DRAFT (2002)).
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) - - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - - -


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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