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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	818-08-6
Chemical Name	Dibutyltin oxide
Substance ID	H26-B-051, R-022
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
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)
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

PHYSICAL HAZARDS

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 present in the molecule associated with explosive properties.
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	- -	-	-	It is described in ICSC (1999) that it is combustible, but the classification is not possible due to no data.
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	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 279 deg C (ICSC (1999)).
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	- -	-	-	Because there is the observation result that it is insoluble in water (ICSC (1999)), it is estimated that it does not react vigorously with water.
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (Sn). However, the classification is not possible due to no data.
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.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P361+P364 P264 P270 P321 P330 P405 P501	There are three reports of LD50 values of 172 mg/kg, 260 mg/kg (SIDS (2009)), and 520 mg/kg (EHC 15 (1980)) for rats. Since two cases correspond to Category 3, and one case corresponds to Category 4, it was classified in Category 3, to which the larger number of values corresponds. Besides, although there are also reports of 44.9 mg/kg and 50 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)), since the information source is RTECS and these data are not adopted in SIDS (2009), they were not adopted for this classification because of insufficient reliability. New information sources were added (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009), and EHC 15 (1980)), and the category was revised.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the reports of an LD50 value of > 2,000 mg/kg (SIDS (2009)) for rats, and an LD50 value of > 2,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)) for rabbits, it was classified as "Not classified." New information sources (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)) were added, and the category was revised.
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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	As a result of occlusive application of 0.5 mL of the undiluted liquid of this substance to rabbits for 4 hours, very mild to mild edema and erythema were observed. There is a report that the edema resolved within 72 hours but the erythema persisted throughout the observation period (14 days) (SIDS (2009)). In addition, there is a description that this substance may irritate the skin and cause burns and pain (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)). From the results above, it was classified in Category 2. The information in SIDS (2009) was added, and the category was revised. Besides, although it was considered as mild irritation for this study in SIDS (2009), it was classified based on the persistent erythema.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	There is a report that in an eye irritation test with rabbits (OECD TG 405), the maximum score was 19.5 (maximum value 110), and the corneal edema, corneal neovascularization, and formation of scleral veins were observed, and the irritation of the cornea persisted after 21 days (SIDS (2009)). From the result above, it was classified in Category 1. The classification was revised due to this update of the information.
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. As for in vitro, it was negative in bacterial reverse mutation tests (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a teratogenicity study by the oral route (gavage) with rats, at a dose (19.9 mg/kg) where no maternal toxicity was observed, external malformations (cleft mandible, cleft lower lip, ankyloglossia, schistoglossia, exencephaly) and skeletal malformations (fused mandibula, cranial hypoplasia, fused ribs, absence of ribs, fused vertebral arches, cleft maxilla) were observed (SIDS (2009)). In the previous classification, since there was no information on maternal toxicity, it was classified in Category 2. However, since it was found that maternal toxicity was not observed, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	This substance is irritating to the respiratory tract. It may also affect the central nervous system and cause dysfunction, which may lead to death. Inhalation and oral ingestion may cause headaches, tinnitus, memory loss and disorientation (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010)). In experimental animals, there is a description that as a result of oral administration of 164-176 mg/kg of this substance to rats, substance-related behavioral changes such as dyspnea, sedation, diarrhea, and increased aggressiveness were suggested (SIDS (2009)). There are no relevant findings on effects on the lungs and liver. Effects on experimental animals were observed within the guidance value range for Category 1. From the above, since this substance is considered to have effects on the central nervous system and respiratory tract irritation, it was classified in Category 1 (central nervous system) and Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There are no findings on repeated exposure for this substance, and therefore, classification is not possible due to lack of data. Besides, there is a description that this substance is converted to dibutyltin dichloride (CAS: 683-18-1) in artificial gastric juice (Environmental Risk Assessment for Chemical Substances Vol.8 (Ministry of the Environment, 2010), SIDS (2009)). In the previous classification, it was classified in Category 1 (liver, kidney) by List 3 information sources, but the data estimated to be the basis was not specified in List 1 information sources. Strictly speaking, it was presumed that classification was conducted based on hazards, not of this substance but those of dibutyltin compounds which are mainly present in the test results for dibutyltin dichloride.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 2	- -	H401	P273 P501	It was classified in Category 2 from 48-hour EC50 = 1.5 mg DBTO/L for crustacea (Daphnia magna) (SIDS, 2006, CICAD 73, 2006).
11	Hazardous to the aquatic environment (Long-term)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (a degradation rate by BOD = 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1984)), and 48-hour EC50 = 1.5 mg DBTO/L for crustacea (Daphnia magna) (SIDS, 2006, CICAD 73, 2006), it was classified in Category 2.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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