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

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GENERAL INFORMATION
 
Item Information
CAS RN 102-06-7
Chemical Name 1,3-Diphenylguanidine
Substance ID m-nite-102-06-7_v2
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) MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link) MHLW Website (in Japanese Only)
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 molecules. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
7 Flammable solids Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive or self-reactive properties present in the molecule. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
10 Pyrophoric solids Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - It is an organic compound not containing oxygen, fluorine or chlorine. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
15 Organic peroxides Not classified (Not applicable)
-
-
- - The organic compound not including peroxy group in molecule. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Gases) Not classified (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". FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
3 Serious eye damage/eye irritation Category 2


Warning
H319 P305+P351+P338
P337+P313
P264
P280
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
4 Respiratory sensitization Classification not possible
-
-
- - Classification is not possible since there is no data. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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)). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects)


Warning
H336 P304+P340
P403+P233
P261
P271
P312
P405
P501
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). FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
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. FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data FY2008 GHS Classification Guidance by the Japanese Government (Sep, 2008)

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
It was classified in Category 2 from 96-hour EC50 = 1.7 mg/L for algae (Raphidocelis subcapitata) (SIDS, 2002). FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11 Hazardous to the aquatic environment Long term (Chronic) Category 2


-
H411 P273
P391
P501
It was classified in Category 2 due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1976)) and 72-hour NOErC = 0.18 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002)). FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol. FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))


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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