GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 78-04-6 |
| Chemical Name | Dibutyltin maleate |
| Substance ID | H28-A-024, C-069A |
| 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 |
- |
- | - | Solid (GHS definition). |
| 3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition). |
| 5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition). |
| 6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 7 | Flammable solids | Classification not possible |
- |
- | - | No data available. |
| 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 | Not applicable |
- |
- | - | Solid (GHS definition). |
| 10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 sparingly soluble in water was obtained (GESTIS (Access on June 2016)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | No data available. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
Based on the LD50 value of 510 mg/kg (OECD TG 401) for rats, this substance was classified in a Category 4 (SIDS (2009)). |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Category 2 |
 Danger |
H330 |
P304+P340
P403+P233 P260 P271 P284 P310 P320 P405 P501 |
Based on the LC50 value (4 hours) of 317 mg/m3 for rats, this substance was classified in Category 4 (SIDS (2009)). |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - |
It is reported that this substance is non-irritating in humans (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)). However, this substance was classified as "classification not possible" due to study details unknown. |
| 3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
Since in an eye irritation test using rabbits, irritation was observed (SIDS (2009)), this substance was classified in Category 2. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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, the bacterial reverse mutation test was negative (SIDS (2009), Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Since ACGIH classified organotin compounds as A4 (ACGIH (7th, 2001)), this substance was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Category 1B |
 Danger |
H360 |
P308+P313
P201 P202 P280 P405 P501 |
As a result of administering by gavage at approx. 28 mg/kg using female rats on Day 8 of gestation, although maternal toxicity is unknown as there is no description that toxicity of maternal animals occurred or not, teratogenicity including external malformations (cleft mandible, cleft lower lip, ankylogenesis, schistoglossia, encephalocele etc.) and skeletal malformations (anomaly of rib, vertebra) etc. were observed in fetuses (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)). Therefore, although the presence or absence of maternal toxicity is unknown, emphasizing that this substance showed teratogenicity, the substance was classified in Category 1B. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (respiratory organs) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
No single exposure data for human are available. As for experimental animals, it is described that in a 4-hour single inhalation study using rats, mottled lungs, nose secretions, fluid in the thoracic cavity and edema were observed as macroscopic findings at doses of 0.212 mg/L or above (SIDS (2009)). Therefore, this substance was classified in Category 1 (respiratory organs). Besides, in the above single inhalation exposure test using rats, it is described that sedation, dyspnoea, ruffled fur, and curved position were observed, while in single dose test orally administered, at the dose of 250 mg/kg which is less than LD50, dyspnoea, ruffled fur, sedation, exophthalmus, and diarrhea were observed (SIDS (2009)). In addition, it is reported that this substance is converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in a hydrolysis test in artificial gastric solution (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), SIDS (2009)), and its conversion rate is 100% (SIDS (2009)). Therefore, in the case of oral intake, it is considered that this substance may indicate the same effect as dibutyltin dichloride. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, immune system) |
Danger |
H372 |
P260
P264 P270 P314 P501 |
No data are available for humans and 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. This substance is converted to dibutyltin dichloride (CAS RN 683-18-1) with a half-life of less than 30 minutes in a hydrolysis test in artificial gastric solution (Environmental Risk Assessment for Chemical Substances Vol. 8 (Ministry of the Environment, 2010), SIDS (2009)), and its conversion rate is 100% (SIDS (2009)). Therefore, it is considered that this substance shows the same target organ as dibutyltin dichloride (CAS RN 683-18-1). In dibutyltin dichloride, the effects on the liver were observed at 1.17 mg/kg/day, which is equivalent to Category 1, and an effect on the immune system was observed at 0.39 mg/kg/day, which is 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 the same effect on the liver and immune system occurs at doses equivalent to Category 1 (the effect on the liver at 1.3 mg/kg/day, the effect on the immune system at 0.44 mg/kg/day as converted by the molecular weight). 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 = 0.184 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 2 due to being not rapidly degradable (BIOWIN), and 72-hour NOEC = 0.77 mg/L for algae (Desmodesmus subspicatus) (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 1 due to being not rapidly degradable (BIOWIN), and 48-hour EC50 = 0.184 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 by drawing a comparison between the above results. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* 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. |