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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	77-58-7
Chemical Name	Dibutyltin dilaurate
Substance ID	24A6056
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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 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	- -	-	-	It is combustible (ICSC (J) (1995)), but the classification is not possible due to no data in the prescribed test.
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	- -	-	-	The substance contains a metal (Sn), but from data on water solubility: 3 mg/L (25 deg C) (SRC PhysProp (Access on July 2012)), 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) which 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.
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

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 P264 P270 P321 P330 P405 P501	There are reports on three LD50 values for rats [175 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), 45 mg/kg, and 243 mg/kg (both EHC 15 (1980))], one corresponds to Category 2, and two correspond to Category 3. Therefore, it was classified in Category 3 to which most corresponded. Besides, as for health hazards, also refer to ID427 dibutyltin oxide (CAS RN 818-08-6), the hydrolysate.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on an LD50 value of > 2,000 mg/kg for rabbits (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	It was classified in Category 2 based on an LC50 value by 2-hour exposure of 0.15 mg/L for mice (converted 4-hour equivalent value: 0.075 mg/L) (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)). Besides, because the LC50 value was higher than the saturated vapour pressure concentration (0.0008 mg/L), it was regarded as a test on a mist or dust.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It was classified in Category 2 because there was moderate irritation in a test in which 500 mg was applied to the rabbit skin for 24 hours (HSDB (2010)). Besides, it is described in List 3 information that there was severe irritation in a Draize test in which 500 mg was applied to the rabbit skin (RTECS (2011): the original article, National Technical Information Service: OTS0555424).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was classified in Category 2A because it is described that it irritates the eye in humans, and redness occurs when in eyes (Environmental Risk Assessment for Chemical Substances vol. 8 (Ministry of the Environment, 2010)), and there was moderate irritation in a test in which 100 mg was applied to the rabbit eye (HSDB (2010)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it was reported to be negative in an Ames test (NTP DB (1983)).
6	Carcinogenicity	Classification not possible	- -	-	-	No data available. Besides, organic tin compounds were classified in A4 for carcinogenicity in ACGIH (2001).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	In a test by oral administration of 51 mg/kg of this substance to rats on a gestational day 8, no effects on body weight and survival of maternal animals and the number of live fetuses were observed, but significant increases in external malformations such as cleft mandible, cleft lower lip, ankyloglossia, schistoglossia, and encephalocele and skeletal malformations such as poorly fixed mandibular bone, skull hypoplasia, and fused ribs were found in fetuses (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). From the above, because teratogenicity was shown at the dose where general toxicity did not occur in parent animals, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver)	Danger	H372	P260 P264 P270 P314 P501	In a 15-day repeated oral administration test with male rats (0, 17.5 mg/kg/day), 20% of animals died in the 17.5 mg/kg/day group, and decreases in the activities of hepatic microsomal enzymes, a significant increase in heme oxygenase activity, and degeneration of hepatocytes were observed (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). And in a 6-week repeated oral administration test with rabbits (0, 15, 25, 40 mg/kg/day), all in the groups at or above 25 mg/kg/day and 1/3 animals in the 15 mg/kg/day group died, and an increase in LDH in the 25 mg/kg/day group, increases in GOT, triglyceride, and total cholesterol in the groups at or above 25 mg/kg/day, and an increase in GPT in the 40 mg/kg/day were found (Environmental Risk Assessment for Chemical Substances vol. 7 and vol. 8 (Ministry of the Environment, 2009 and 2010)). From the above, rats showed changes in the activities of hepatocellular microsomal enzymes and degeneration of hepatocytes at 17.5 mg/kg/day (converted guidance value: 2.92 mg/kg/day) corresponding to the guidance values for Category 1, and rabbits showed increases in GOT, GPT, LDH, etc. indicating deterioration of liver function at or above 25 mg/kg/day (converted guidance value: 11.5 mg/kg/day), or at 40 mg/kg/day (converted guidance value: 18.5 mg/kg/day) corresponding to the guidance values for Category 2. Therefore, it was classified in Category 1 (liver).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour LC50 = 0.66 mg/L for crustacea (Daphnia magna) (ECETOC TR91, 2003).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (not readily degradable, BOD: 50% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1985)), and it was classified in Category 1 in acute toxicity.
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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