NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1461-22-9
Chemical Name	Tributyltin chloride
Substance ID	H26-B-054, R-023
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	It was classified as "Not classified" based on a flash point of 110 deg C (unknown test methods) (GESTIS (Access on July 2014)).
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
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 classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 150 deg C (NITE Chemical Risk Information Platform (NITE-CHRIP) (Access on August 2014)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Because data of water solubility of 17 mg/L (20 deg C) (GESTIS (Access on July 2014)) were obtained, it is estimated that it does not react vigorously with water.
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine (but not fluorine or oxygen), and the chlorine is chemically bonded to the element other than carbon or hydrogen (Sn). However, the classification is not possible due to no data.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	No data 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	Based on the report of an LD50 value of 122 mg/kg for rats (SIDS (2010), DFGOT vol. 1 (1991), EHC 116 (1990)), it was classified in Category 3.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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	There are reports that in a skin irritation test with rats, necrosis and erythema of the epidermis were observed within 12-24 hours after application, but the necrotic epidermis peeled from the dermis, and the epidermis regenerated. The erythema resolved 72 hours after application (EHC 116 (1990), SIDS (2010)). In addition, there is a report that as a result of the application of the undiluted liquid of this substance to 5 volunteers, redness, itching, hair follicle inflammation, and mild edema occurred (SIDS (2010)). Based on the above result, it was classified in Category 2.
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Because there are descriptions that this substance is severely irritating to rabbits' eyes (DFGOT vol. 1 (1991)) and that "it is seriously irritating to the eyes" for human health effects (HSDB (Access on July 2014)), it was classified in Category 2A.
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	- -	-	-	As for in vivo, it was negative in a micronucleus test with bone marrow cells of mice (SIDS (2010)), as for in vitro, it was negative and positive in bacterial reverse mutation tests and negative in a mammalian cell chromosome aberration test (SIDS (2010), ATSDR (2005)). Therefore, it was classified as "Classification not possible."
6	Carcinogenicity	Classification not possible	- -	-	-	It is classified as A4 in ACGIH (7th, 2001) as an organic tin compound. Therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	It was reported that in a two-generation reproduction toxicity test with rats by the oral route (feeding), reproductive effects (decreases in litter size, live birth index, pup body weight and pup body weight gain) were observed at a dose (10 mg/kg/day) where maternal toxicity (decreased body weight gain) appeared, and even at a dose (0.4 mg/kg/day) where maternal toxicity did not appear, effects on pups' genetic organs (decreases in weight of the testis and epididymis, decreases in spermatid and sperm counts, increased AGD (anogenital distance) in female pups) were observed (SIDS (2010)). There is a report that in a teratogenicity test with rats by the oral route (gavage), embryo loss, decreased fetal body weight gain, and teratogenicity (mainly cleft palate) were observed at a dose (25 mg/kg/day) where maternal toxicity (decreased body weight gain) appeared (SIDS (2010)). Although it was impossible to classify because of no data in the previous classification, the new information available for classification having been obtained. Therefore, it was classified in Category 1B.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, liver), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	There are no hazard findings on single exposures in humans. In experimental animals, there are reports of slight irritation in the nose and inflammatory changes in the respiratory tract by inhalation exposure to rats (SIDS (2010)), and reports of damage to the common ductus hepaticus and common bile duct, ulcerative inflammation of the bile duct, and necrosis of the bile duct at or above 29.6 mg/kg by oral dose to Syrian hamsters (ATSDR (2005), Takagi et al. (1992)). Necrotic pneumonia, gastrointestinal tract bleeding or hyperemia were observed in dead animals from an oral dose of 45-250 mg/kg to rats (SIDS (2010)). A significant increase in the enzyme (ornithine carbamyl transferase in the blood) which is the index for hepatotoxicity was shown at 58 mg/kg by oral dose to mice (ATSDR (2005)). In other, hunched back and piloerection were observed at 187.5 mg/kg after oral dose to mice, and sluggishness, piloerection, hunched back and closeness were observed at 375-2,000 mg/kg (SIDS (2010)). In addition, there is a description that "tributyltin compounds could possibly damage the central nervous system." (DFGOT vol. 1 (1991)). The effects on the liver and the central nervous system in experimental animals were observed within the guidance value range for Category 1. In the previous classification, there is a description of "a steatosis of the liver cells, traces of lipids in the renal tubule cells, hemorrhages in the digestive tract and kidneys" (EHC 116 (1990)), and it was classified in Category 2 (liver, kidney). However, EHC rejected these findings (based on 500 mg/kg oral dose to mice) because no right conclusion can be drawn due to no clear evidence concerning steatosis of the liver and kidney. Therefore, this finding was not adopted. Moreover, because there are no findings of effects on the kidney, the kidney was not adopted as a target organ. Besides, it is described that organic tin compounds may be irritating to the respiratory tract (ATSDR (2005), ACGIH (7th, 2001)). From the above, although there are no findings on humans, from the data in experimental animals, respiratory tract irritation was considered for this substance in addition to the effects on the central nervous system and liver. Therefore, it was classified in Category 1 (central nervous system, liver), Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 1 (immune system, respiratory organs, liver)	Danger	H372	P260 P264 P270 P314 P501	There are no hazard findings on repeated exposures in humans. In experimental animals, in a test in which rats were dosed by feeding for 14 days or 28 days, at doses (0.75-9.2 mg/kg/day (converted guidance value: 0.12-2.86 mg/kg/day)) within the range of Category 1, the effects on the immune system such as the effects on the thymus (reduction of thymus weight, reduction in thymus cell counts, lymphocytes depletion), decreased spleen weights, reddening in the mesenteric lymph nodes were observed, and an increase in relative liver weight was also observed (SIDS (2010), DFGOT vol. 1 (1991)). In addition, there is a report that in a test in which rats were exposed by inhalation of this substance (estimated as mist state) for 95 days, lung hyperemia, catarrhal bronchitis and fatty degeneration of the liver were observed at the concentration of 0.3 ppm (4 mg/m3: 0.004 mg/L/6 hours) (ATSDR (2005)). From the above, based on the findings on experimental animals, it was classified in Category 1 (immune system, respiratory organs, liver).
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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour EC50 = 0.99 microg TBTC/L for algae (Skeletonema costatum) (SIDS, 2007).
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 1 due to being not rapidly degradable (a 28-day degradation rate by BOD according to OECD TG 301F: 0% (SIDS, 2007)), and 96-hour NOEC = 1.2 microg TBTC/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2007). 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 (a 28-day degradation rate by BOD according to OECD TG 301F: 0% (SIDS, 2007)), and 96-hour LC50 = 1.1 microg TBTC/L for crustacea (Mysidopsis bahia) (SIDS, 2007, ECETOC TR91, 2003). From the above results, it was classified in Category 1.
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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