NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	10584-98-2
Chemical Name	Dibutyltin bis(2-ethylhexylthioglycolate)
Substance ID	m-nite-10584-98-2_v1
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	A flash point is 149 deg C (closed cup) (GESTIS (Access on June 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metalloid (Sn), but it is estimated that it does not react vigorously with water because the observation result of being practically insoluble in water was obtained (GESTIS (Access on June 2016)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, for rats, 4 LD50 values for mixtures of this substance and the monobutyl form of this substance (CAS No. 26864-37-9, abbreviation: MBT (EHTG)) are described in SIDS (2009). These 4 are 4,439 mg/kg (equivalent to OECD TG 401, mixing ratio of 65:35), 396 mg/kg (equivalent to OECD 401, mixing ratio of 61.8:25.3, 12.9% of soybean oil used as vehicle), 615 mg/kg (equivalent to OECD TG 401, mixing ratio of 61.8:25.3, 12.9% of polyethylene glycol used as vehicle), 758 mg/kg (equivalent to OECD TG 401, mixing ratio of 65:35). Three items correspond to Category 4, and one corresponds to "Not classified" (Category 5 in UN GHS classification).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, 2 LD50 values for mixtures of this substance and the monobutyl form of this substance (CAS RN 26864-37-9, abbreviation: MBT (EHTG)) for rats are described in SIDS (2009). These 2 are > 1,000 mg/kg (OECD TG 402, mixing ratio of 61.8:25.3, 12.9 % of soybean oil used as vehicle), 777 mg/kg (equivalent to OECD TG 402, mixing ratio of 72:14, 14 % of soybean oil as vehicle). One corresponds to Category 4 to "Not classified," and the other corresponds to Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, data for dibutyltin bis (isooctylthioglycolate) (CAS RN 25168-24-5, abbreviation: DBT (IOTG)) which is an analogous substance are described in SIDS (2009). 　Due to the description of "this substance DBT(EHTG) and DBT(IOTG) are isomers and are considered toxicologically equivalent" and the description of the LC50 value for DBT (IOTG) (1 hour, equivalent to OECD TG 403, male and female) of 22 mg/L (converted 4-hour equivalent value: 5.5 mg/L) for rats, the data corresponds to "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	No data are available on only this substance. 　However, from the report that in a skin irritation test (OECD TG 404) using rabbits for a mixture of this substance and butyltin tris (2-ethylhexyl thioglycolate) (80:20), it was corrosive, the substance was classified as an irritant to the skin in SIDS (SIDS (2009)). 　Therefore, this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	No data is available on only this substance. 　However, it is reported that in an eye irritation test (OECD TG 405) for a mixture of this substance and butyltin tris (2-ethylhexyl thioglycolate) (65:35) using rabbits, it was slightly irritating. The substance was classified as a slight irritant to the eye in SIDS (SIDS (2009)). Therefore, this substance was classified in Category 2B.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In a skin sensitization test (maximization test, OECD TG 406) using guinea pigs for a mixture of this substance and butyltin tris (2-ethylhexyl thioglycolate) (80:20), sensitization (Sensitization Rate = 55%) was observed. 　In addition, also, in a skin sensitization test (maximization test, OECD TG 406) using 2-ethylhexyl thioglycolate, it was positive. 　From these results, this substance was classified as a skin sensitizer in SIDS (SIDS (2009)). Therefore, this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There is no in vivo data. 　As for in vitro, bacterial reverse mutation tests were negative for a mixture of this substance and butyltin tris(2-ethylhexylthioglycolate) (65:35) (SIDS (2006)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Since organotin compounds are classified as A4 in ACGIH (ACGIH (7th, 2001)), this substance was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproduction/developmental toxicity screening test (OECD TG 421) using rats administered by gavage, death, moribundity, decreased body weight gain, increased liver and kidney weight, and hepatocellular vacuolization were observed in parental animals. 　At the high dose (150 mg/kg/day), there was no effect on fertility, but decreased viability and growth of the pups through post-partum Day 4 were observed (SIDS (2009)). There is no developmental toxicity test report using pregnant animals. 　Therefore, based on the decrease in viability of the pups at a parental animal toxicity dose in the screening test, this substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	No data are available for single exposure in humans. 　As for experimental animals, it is reported in a 1-hour single inhalation exposure test using rats in an isomer of this substance, dibutyltin bis(isooctyl thioglycolate) (CAS RN 25168-24-5, abbreviation: DBT (IOTG)), at a concentration of 5 mg/L (converted 4-hour equivalent value: 1.25 mg/L), bleeding in the lungs, enlarged thymus, adhesions in the chest cavity, and dark spleen were observed (SIDS (2009)). 　It is also described that since this substance and DBT (IOTG) are isomers differing only slightly in structure, they can be considered toxicologically equivalent (SIDS (2009)). 　Therefore, this substance was classified in Category 2 (respiratory organs). 　Besides, it is also reported that in a single oral dose using rats for mixtures of 62-65% of this substance and 25-35% of the monobutyl form, dyspnoea, ruffled fur, curved body position, exophthalmos, sedation and diarrhea were observed (SIDS (2009)). 　In addition, it is reported that this substance converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in hydrolysis tests in artificial gastric fluid (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), SIDS (2009)) and that its conversion rate is 97% (SIDS (2009)). 　Therefore, in the case of oral intake, it is considered that this substance may also indicate the similar effect to dibutyltin chloride.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, immune system)	Danger	H372	P260 P264 P270 P314 P501	No data is available for humans or experimental animals for this substance. 　However, for dibutyltin compounds which convert to dibutyltin oxide and dibutyltin chloride in the body, it is considered that their toxicity can be adopted in common. 　This substance converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in hydrolysis tests in artificial gastric fluid (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), SIDS (2009)). Its conversion rate was 97% (SIDS (2009)). 　Therefore, it is considered that this substance shows the similar target organ to dibutyltin dichloride (CAS RN 683-18-1). 　In dibutyltin dichloride, effects on the liver were observed at 1.17 mg/kg/day, which is equivalent to Category 1, and effects on the immune system were observed at not less than 0.39 mg/kg/day, which is equivalent to Category 1. 　Since the molecular weight of dibutyltin dichloride is 303.8, and the molecular weight of this substance is 639.6, it is estimated that the effect of this substance on the liver and immune system also occur at doses equivalent to Category 1 (converted value from molecular weight: 2.5 mg/kg/day (effects on the liver), 0.8 mg/kg/day (effects on the immune system)). 　Therefore, this substance was classified in Category 1 (liver, immune system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour EC50 = 0.017 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 21-day NOEC (reproduction) = 0.047 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). 　If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to not being rapidly degradable (BIOWIN), and 96-hour LC50 = 5.7 mg/L for fish (Danio rerio) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). 　It was classified in Category 1 by drawing a comparison between the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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