GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 77-58-7
Chemical Name Dibutyltin dilaurate
Substance ID R03-C-020-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2012  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives -
-
-
- - -
2 Flammable 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 -
-
-
- - -
17 Desensitized explosives -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation -
-
-
- - -
3 Serious eye damage/eye irritation -
-
-
- - -
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization -
-
-
- - -
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (5), it was classified in Category 2 in consideration of the findings on dibutyltin dichloride, which is a hydrolysate of this substance in the stomach. Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) As for in vivo, positive results were reported in a comet assay using the rat cerebral cortical cells after 7-week repeated oral administration (CLH Report (2014), ECHA RAC Opinion (2015)).
(2) As for in vitro, this substance was all negative in four bacterial reverse mutation tests (CLH Report (2014), ECHA RAC Opinion (2015), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2018)).
(3) For dibutyltin dichloride (DBTC, CAS RN 683-18-1), which is a hydrolysate of this substance in the stomach, as for in vivo, in two in vivo micronucleus tests (OECD TG 474, GLP) using mouse bone marrow, positive and negative results were reported. However, since there was no reason to reject either result, the positive results were adopted (CLH Report (2014), ECHA RAC Opinion (2015)).
(4) For DBTC, as for in vitro, in a bacterial reverse mutation assay and a gene mutation test using the cultured mammalian cells, positive and negative results were obtained, and in a chromosomal aberration test using the cultured mammalian cells, positive results were obtained (CLH Report (2014)).
(5) The EU classified this substance in Muta. 2 (EU CLP Classification Results (Accessed Oct. 2021)) in consideration of the data of DBTC in exposure through the oral route since it was suggested from an in vitro test that this substance was hydrolyzed into DBTC in the acidic stomach (CLH Report (2014), ECHA RAC Opinion (2015)).

[Reference Data, etc.]
(6) DBTC, which is a metabolite of this substance, is classified in Category 2 in Japan (GHS classification result in FY2016) and in Muta. 2 in the EU (EU CLP Classification Results (Accessed Oct. 2021)) in the current classification.
6 Carcinogenicity -
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-
- - -
7 Reproductive toxicity -
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-
- - -
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
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10 Aspiration hazard -
-
-
- - -

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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