GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 10584-98-2 |
| Chemical Name | Dibutyltin bis(2-ethylhexylthioglycolate) |
| Substance ID | H28-A-026, C-071A |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 6 | Flammable liquids | Not classified |
- |
- | - | A flash point is 149 deg C (closed cup) (GESTIS (Access on June 2016)). |
| 7 | Flammable solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
| 9 | Pyrophoric liquids | Classification not possible |
- |
- | - |
No data available. |
| 10 | Pyrophoric solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to liquid substances are not available. |
| 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)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. |
| 14 | Oxidizing solids | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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). |
| 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. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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." |
| 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. |
| 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. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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)). |
| 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." |
| 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. |
| 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. |
| 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (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. |
| 11 | Hazardous to the aquatic environment (Long-term) | 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. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - |
No data available. |
NOTE:
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* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |