NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	77-58-7
Chemical Name	Dibutyltin dilaurate
Substance ID	m-nite-77-58-7_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 molecule.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	It is combustible (ICSC (J) (1995)), but the classification is not possible due to no data in the prescribed test.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	The substance contains a metal (Sn), but from data on water solubility: 3 mg/L (25 deg C) (SRC PhysProp (Access on July 2012)), it is estimated that it does not react vigorously with water.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (Sn). However, the classification is not possible due to no data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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	There are reports on three LD50 values for rats [175 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), 45 mg/kg, and 243 mg/kg (both EHC 15 (1980))], one corresponds to Category 2, and two correspond to Category 3. Therefore, it was classified in Category 3 to which most corresponded. Besides, as for health hazards, also refer to ID427 dibutyltin oxide (CAS RN 818-08-6), the hydrolysate.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on an LD50 value of > 2,000 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	It was classified in Category 2 based on an LC50 value by 2-hour exposure of 0.15 mg/L for mice (converted 4-hour equivalent value: 0.075 mg/L) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). Besides, because the LC50 value was higher than the saturated vapour pressure concentration (0.0008 mg/L), it was regarded as a test on a mist or dust.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It was classified in Category 2 because there was moderate irritation in a test in which 500 mg was applied to the rabbit skin for 24 hours (HSDB (2010)). Besides, it is described in List 3 information that there was severe irritation in a Draize test in which 500 mg was applied to the rabbit skin (RTECS (2011): the original article, National Technical Information Service: OTS0555424).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was classified in Category 2A because it is described that it irritates the eye in humans, and redness occurs when in eyes (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), and there was moderate irritation in a test in which 100 mg was applied to the rabbit eye (HSDB (2010)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Classification not possible	- -	-	-	No data available. Besides, organic tin compounds were classified in A4 for carcinogenicity in ACGIH (2001).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a test by oral administration of 51 mg/kg of this substance to rats on a gestational day 8, no effects on body weight and survival of maternal animals and the number of live fetuses were observed, but significant increases in external malformations such as cleft mandible, cleft lower lip, ankyloglossia, schistoglossia, and encephalocele and skeletal malformations such as poorly fixed mandibular bone, skull hypoplasia, and fused ribs were found in fetuses (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). From the above, because teratogenicity was shown at the dose where general toxicity did not occur in parent animals, it was classified in Category 1B.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In a 15-day repeated oral administration test with male rats (0, 17.5 mg/kg/day), 20% of animals died in the 17.5 mg/kg/day group, and decreases in the activities of hepatic microsomal enzymes, a significant increase in heme oxygenase activity, and degeneration of hepatocytes were observed (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). And in a 6-week repeated oral administration test with rabbits (0, 15, 25, 40 mg/kg/day), all in the groups at or above 25 mg/kg/day and 1/3 animals in the 15 mg/kg/day group died, and an increase in LDH in the 25 mg/kg/day group, increases in GOT, triglyceride, and total cholesterol in the groups at or above 25 mg/kg/day, and an increase in GPT in the 40 mg/kg/day were found (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). From the above, rats showed changes in the activities of hepatocellular microsomal enzymes and degeneration of hepatocytes at 17.5 mg/kg/day (converted guidance value: 2.92 mg/kg/day) corresponding to the guidance values for Category 1, and rabbits showed increases in GOT, GPT, LDH, etc. indicating deterioration of liver function at or above 25 mg/kg/day (converted guidance value: 11.5 mg/kg/day), or at 40 mg/kg/day (converted guidance value: 18.5 mg/kg/day) corresponding to the guidance values for Category 2. Therefore, it was classified in Category 1 (liver).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour LC50 = 0.66 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (not readily degradable, BOD: 50% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1985)), and it was classified in Category 1 in acute toxicity.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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