NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	78-04-6
Chemical Name	Dibutyltin maleate
Substance ID	m-nite-78-04-6_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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	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	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	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 solid (melting point <= 140 deg C) 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 sparingly soluble 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)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.	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	- -	-	-	Test methods applicable to solid substances are not 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)	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)).	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	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 preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
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	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))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Since ACGIH classified organotin compounds as A4 (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 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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	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 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).	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	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	In preparation. Check the Japanese version.	FY2022	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.1))

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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