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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1983-10-4
Chemical Name	Tributyltin fluoride
Substance ID	R01-B-088
Classification year (FY)	FY2019
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 (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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	There is information that it is combustible (GESTIS (Access on September 2019)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	It contains a metalloid (Sn), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of 6 mg/L (20 deg C) (GESTIS (Access on October 2019)).
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing fluorine (but not chlorine or oxygen), which is chemically bonded to an element (Sn) other than carbon or hydrogen. However, the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

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	[Rationale for the Classification] Based on (1), it was classified in Category 3. The category was changed from the previous classification by the use of new information sources. [Evidence Data] (1) LD50 for rats: 94 mg/kg (DFGOT vol.1 (1990))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1. Besides, since the exposure concentration was higher than the saturated vapor pressure concentration (2*10-6 mg/L), a reference value in units of mg/L was applied as the dust. The category was changed by reviewing information. [Evidence Data] (1) LC50 (4 hours) for rats: 0.4 ppm (0.005 mg/L) (ACGIH (7th, 2001))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. The category was changed since new data were available. [Evidence Data] (1) This substance had a slight irritant effect on rabbit skin but in a paint, it was shown to cause severe irritation (DFGOT vol.1 (1990)). (2) This substance (solid) had a slight irritant effect on rabbit skin (DFGOT vol.1 (1990)). [Reference Data, etc.] (3) Tributyltin compounds have a strong irritant effect on the skin and mucous membranes (DFGOT vol.1 (1990)). (4) It was classified as "Skin Irrit. 2 (H315)" in EU CLP classification (EU CLP classification (Access on November 2019)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) This substance is an extreme irritant to the eyes of rabbits (ATSDR (2005)). (2) This substance was severely irritating to the eyes of rabbits (DFGOT vol. 1 (1990)). [Reference Data, etc.] (3) Tributyltin compounds have a strong irritant effect on the skin and mucous membranes (DFGOT vol.1 (1990)). (4) It was classified in "Eye Irrit. 2 (H319)" in EU CLP classification (EU CLP classification (Access on November 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There are no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there is a report of it being negative in a chromosomal aberration test with cultured mammalian cells (ATSDR (2005)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, organotin compounds were classified in A4 by ACGIH (ACGIH (7th, 2018)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1), since tributyltin oxide (CAS RN 56-35-9) showed teratogenicity at doses where the maternal toxicity was observed, attention should be paid to tributyltin compounds in general. However, because the reproductive effects of this substance are unknown, it was classified as "Classification not possible" due to lack of data. [Reference Data, etc.] (1) In EHC 116 (1990), the potential embryotoxicity of tributyltin compounds has been evaluated in three mammalian species (mouse, rat, and rabbit) after oral dosing of the mother. The main malformation noted in rat and mouse fetuses was cleft palate, but this occurred at dosages overtly toxic to the mothers. These results are not considered to be indicative of teratogenic effects of tributyltin compounds at doses below those producing maternal toxicity.
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] There are no reports on effects by single exposure to this substance in humans or experimental animals. Based on (1) and (2), it is considered that respiratory tract irritation may occur in cases of inhalation exposure. Therefore, it was classified in Category 3 (respiratory tract irritation). In the previous classification, the central nervous system was also adopted as the target organ because of the general description of organotin compounds in (3). However, it was not adopted since no information to support effects on the central nervous system was available for tributyltin compounds as shown in (4) and (5). Therefore, the classification result was changed. [Evidence Data] (1) There is a description that tributyltin compounds have a strong irritant effect on the skin and mucous membranes (DFGOT vol.1 (1990)). (2) There are descriptions that this substance was irritating to the skin and eyes of rabbits (DFGOT vol.1 (1990)). [Reference Data, etc.] (3) It is described that organotin compounds may have effects on the central nervous system and respiratory tract irritation in humans (ACGIH (7th, 2001), ATSDR (2005)). (4) As for organic tin compounds, a TLV–TWA of 0.1 mg/m3 was recommended by ACGIH to minimize the potential for adverse effects on the immune function and the central nervous system. However, for tributyltin compounds, effects on the immune system are due to repeated exposure, and no information supporting the neurotoxicity effects is described for either a single or repeated exposure (ACGIH (7th, 2001)). (5) There are descriptions that in multiple repeated oral dose toxicity tests with rats and mice using tributyltin oxide (CAS RN 56-35-9) and tributyltin chloride (CAS RN 1461-22-9), neither morphological changes in the central nervous system or behavioral changes were observed (DFGOT vol.1 (1990)). Even in other information sources in List 1 and List 2, no information was available to support the neurotoxicity effects of tributyltin compounds.
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs, immune system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There are no data on this substance itself. However, the classification was conducted based on the data on other tributyltin compounds in consideration of the description in (1). Based on (2)-(4), effects on the immunological system were commonly observed within the range of Category 1 by oral administration of tributyltin compounds to experimental animals, and based on (5), effects on the respiratory organs were observed within the range of Category 1 by inhalation exposure. Therefore, it was classified in Category 1 (respiratory organs, immune system). As a result of reviewing information of the information sources and examining the classification, the classification result was changed from the previous classification. [Evidence Data] (1) Since tributyltin compounds dissociate to form tributyltin hydrate cations, the same species, presumed to be tributyltin chloride, is probably absorbed after ingestion of various tributyltin compounds (DFGOT vol.1 (1990)). (2) In tests in which rats were administered by feeding tributyltin chloride (CAS RN 1461-22-9) for 14 or 28 days, at 0.75-9.2 mg/kg/day (converted guidance value: 0.12-2.86 mg/kg/day, within the range of Category 1), effects on the immune system such as effects on the thymus (decreased weight, decreased thymic cell counts, lymphocyte depletion), decreased spleen weight and reddening in mesenteric lymph nodes were observed, and increased relative liver weight was also observed (SIDS (2010), DFGOT vol. 1 (1990)). (3) In a test in which rats were administered tributyltin oxide (CAS RN 56-35-9) by feeding for 4 weeks, decreased mean corpuscular volume and eosinophils were observed at 0.25 mg/kg/day (converted guidance value: 0.08 mg/kg/day (a converted value equivalent to this substance: 0.04 mg/kg/day), within the range of Category 1), decreased thymus weight was observed at 1 mg/kg/day (converted guidance value: 0.31 mg/kg/day, (a converted value equivalent to this substance: 0.08 mg/kg/day), within the range of Category 1), slight atrophy of the hepatocytes and abnormalities in hematologic test value, etc. were observed at 4 mg/kg/day (converted guidance value: 1.24 mg/kg/day (a converted value equivalent to this substance: 0.65 mg/kg/day), within the range of Category 1), and liver necrosis, bile duct hyperplasia, etc. were observed at 16 mg/kg/day (converted guidance value: 4.98 mg/kg/day (a converted value equivalent to this substance: 2.58 mg/kg/day), within the range of Category 1) (ACGIH (7th, 2001), ATSDR (2005)). (4) In a test in which tributyltin oxide was administered by feeding to rats for 2 years, impairments of the immune system were observed at 5 ppm (0.4 mg/kg/day (a converted value equivalent to this substance: 0.1 mg/kg/day), within the range of Category 1) (ACGIH (7th, 2001)). (5) When rats were exposed by inhalation to 0.30-0.45 ppm (4-6 mg/m3) of tributyltin chloride (presumed as the mist state) (6 hours/day) for 95 days, lung hyperemia, catarrhal bronchitis, minor fatty degeneration in the liver, and inflamed eyes and nostrils were observed at 0.3 ppm (0.0004 mg/L) (a converted value equivalent to this substance: 0.0004 mg/L, within the range of Category 1) (ATSDR (2005)). [Reference Data, etc.] (6) As for organotin compounds, ACGIH recommends a TLV-TWA of 0.1 mg/m3 to minimize adverse effects on the immune function and the central nervous system (ACGIH (7th, 2001)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.00025 mg/L for crustacea (Daphnia magna) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2020).
11	Hazardous to the aquatic environment Long term (Chronic)	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 (BIOWIN), and it was classified in Category 1 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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