NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	25168-24-5
Chemical Name	Dibutyltin bis(isooctyl thioglycolate)
Substance ID	m-nite-25168-24-5_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	Classification not possible	- -	-	-	No data available.	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 for an analog substance, Dibutyltin bis(2-ethylhexyl thioglycolate) (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, in rats, 2 LD50 values (OECD TG 401) for mixtures of this substance and the monobutyl form of this substance (CAS RN 25852-70-4, abbreviation: MBT (IOTG)) are described in SIDS (2009) (mixing ratio of 67:33, 2,086 mg/kg and 3,088 mg/kg). Both data are equivalent to "Not classified" (Category 5 of 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 were reported in SIDS (2009) for the mixtures of an analogous substance, dibutyltin bis (2-ethylhexyl thioglycolate) (CAS RN 10584-98-2, abbreviation: DBT (EHTG)) and the monobutyl form of DBT (EHTG) (CAS RN 26864-37-9, abbreviation: MBT (EHTG)). It is described that DBT (EHTG) and this substance, DBT (IOTG) are isomers and are considered toxicologically equivalent. Also, in rats, the LD50 values for a mixture of DBT (EHTG) and MBT (EHTG) are > 1,000 mg/kg (OECD TG 402, a mixing rate of 61.8:25.3 with 12.9% of soybean oil as a vehicle) and 777 mg/kg (comparable to OECD TG 402, a mixing ratio of 72:14 with 14% of soybean oil as a vehicle). One is equivalent to Category 4 and "Not classified," and the other is equivalent 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)	Not classified	- -	-	-	This substance was classified as "Not classified," based on the LC50 value of 22 mg/L (1 hour, comparable to OECD TG 403, 4-hour converted value: 5.5 mg/L, males and females) for rats (SIDS (2009)). Since the LC50 value was higher than the saturated vapor concentration (0.00000297 ppm (converted value: 0.078 ng/L)), the reference value in the unit mg/L was applied as mists.	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	In a skin irritation test (4-hour application) (OECD TG 404) using rabbits, a mixture of this substance and the monobutyl form (CAS RN 25852-70-4, abbreviation: MBT (IOTG)) (95:5) was reported to be corrosive (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 1	Danger	H318	P305+P351+P338 P280 P310	Eye irritation tests using rabbits were reported to be slightly irritating (SIDS (2009)). Moreover, because this substance was classified in Category 1 in skin corrosion/irritation, it was classified in Category 1.	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 study (maximization test, OECD TG 406) using guinea pigs, a mixture of this substance and butyltin tris (isooctylthioglycolate) (67:33) was sensitizing (Sensitization Rate = 40-95%), and SIDS determined this substance as a sensitizer (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. 　No in vivo data available. As for an in vitro test, the result was negative for the bacterial reverse mutation test (SIDS (2009)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Since organotin compounds were classified in A4 by 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	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))
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	No data available for single exposure to humans. As for experimental animals, it was reported that in a 1-hour single inhalation exposure test, at the concentration of 5mg/L (4 hour converted value of 1.25 mg/L), blood in the lungs, enlarged thymus, adhesions in the chest cavity, and dark spleen were observed (SIDS (2009)). Therefore, this substance was classified in Category 2 (respiratory organs). 　Besides, it was reported that by single oral administration with a 67:33 mixture of this substance and the monobutyl form, rats exhibited dyspnoea, ruffled fur, ventral body position, exophthalmos, sedation, and salivation at 500 mg/kg (SIDS (2009)). 　Moreover, dibutyltin bis(2-ethylhexyl thioglycolate) (CAS RN 10584-98-2), which is an isomer of this substance, is converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in hydrolysis tests in artificial gastric solution (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment) (2010), SIDS (2009)). It is described that its conversion rate is 97% and it is estimated that this substance will undergo hydrolysis at the similar rate (SIDS (2009)). Therefore, this substance may also be converted into dibutyltin dichloride in vivo, and in the case of oral intake, it is considered that this substance may also indicate the similar effect to dibutyltin dichloride.	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 available for humans or experimental animals. 　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. 　It is reported that dibutyltin bis(2-ethylhexyl thioglycolate) (CAS RN 10584-98-2), which is an isomer of this substance, is converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in hydrolysis tests in artificial gastric solution (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), SIDS (2009)). It is described that its conversion rate is 97% and this substance will be expected to undergo hydrolysis at a similar rate. 　Therefore, it is considered that this substance shows effects on the same target organ as dibutyltin dichloride (CAS RN 683-18-1). 　For dibutyltin dichloride, the effects on the liver were observed at 1.17 mg/kg/day, which is equivalent to Category 1, and the effect on the immune system was observed at 0.39 mg/kg/day, equivalent to Category 1, or above. 　Since the molecular weight of dibutyltin dichloride is 303.8, and the molecular weight of this substance is 346.98, it is estimated that this substance also shows the effect on the liver and the immune system at doses equivalent to Category 1 (the effect on the liver at 2.5 mg/kg/day, the effect on the immune system at 0.8 mg/kg/day as converted from molecular weight). 　Thus, 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)	Classification not possible	- -	-	-	The classification is not possible because data are not obtained for Dibutyltin bis(isooctyl thioglycolate) (DBT(IOTG)). 　Besides, it is written in SIDS (2006) that DBT(IOTG) and Dibutyltin bis(2-ethylhexyl thioglycolate) (DBT(2-EHMA)) are isomers and have similar toxicological properties, and the ecological toxicity of DBT (IOTG) was evaluated using the data on DBT(2-EHMA). However, because a hydrolysis degradation rate varies from one dibutyltin compound to another, and it is estimated that parent substances also exist for a considerable time, the classification was not conducted using the data on DBT(2-EHMA) for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	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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