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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	900-95-8
Chemical Name	Fentin acetate
Substance ID	H26-B-052, -
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 combustible (a flash point of 185 plus or minus 5 deg C is described in Pesticide Manual (14th, 2006)), but the classification is not possible due to no data obtained with prescribed test methods.
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 an agricultural chemical, and it is estimated that it does not spontaneously ignite in contact with air at normal temperatures.
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 data of water solubility of about 9 mg/L (20 deg C) (HSDB (Access on July 2014)) were obtained, 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 seven reports of LD50 values of 136 mg/kg (males) and 136 mg/kg (EHC 15 (1980)), 140 mg/kg and 298 mg/kg (JMPR 827 (1991)), 140–298 mg/kg (CICAD 13 (1999)), 136-491 mg/kg (PIM 589 (1994)), and 491 mg/kg (males) (ACGIH (7th, 2001), EHC 15 (1980)) for rats. It was classified in Category 3, to which the larger number of values corresponds.
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P280 P312 P321 P361 P364 P405 P501	There are four reports of LD50 values of 450 mg/kg (males) (EHC 15 (1980)), 450 mg/kg (PIM 589 (1994)), and > 2000 mg/kg (CICAD 13 (1999), JMPR 827 (1991)) for rats, and an LD50 value of approximately 125 mg/kg (PIM 589 (1994)) for rabbits. It was classified in Category 3, to which the larger number of values corresponds.
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)	Category 1	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	There are reports of LC50 (4 hours) values of 0.044 mg/L (females) and 0.069 mg/L (females) for rats (JMPR 827 (1991)). It was classified in Category 1, to which the minimum value of LC50 corresponds. Besides, since LC50 values are higher than the saturated vapor concentration (3.17*10-4 mg/L), the reference value of the dust was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	There are reports that no irritation was observed in tests where the substance was applied to rabbit skin (CICAD 13 (1999), JMPR 827 (1991)). On the other hand, it is suggested that this substance may be irritating (HSDB (Access on July 2014)). Based on the above results, this substance was considered to cause mild irritation and it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, this substance is classified as "Xi; R38" in EU DSD classification, and "Skin Irrit. 2 H315" in EU CLP classification.
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Based on a report that in an eye irritation test with rabbits, the rabbits were slaughtered 72 hours after application because severe injury developed and this did not resolve (CICAD 13 (1999), JMPR 827 (1991)), it was classified in Category 1.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Since there is a report that in a skin sensitization test (Buehler Test) with guinea pigs, sensitization was observed (CICAD 13 (1999)), it was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no in vivo data on this substance, and as for in vitro, it was negative in a chromosome aberration test with cultured mammalian cells, and positive in a micronucleus test and a sister chromatid exchange test with cultured mammalian cells (ATSDR (2005)). Besides, as for in vivo, there is a report that it was negative in a dominant lethal test with rodents for triphenyltin compounds (ACGIH (7th, 2001)). In addition, it was concluded in CICAD 13 (1999) that triphenyltin compounds were not genotoxic.
6	Carcinogenicity	Classification not possible	- -	-	-	It is classified in A4 as organic tin compounds in ACGIH (7th, 2001). Therefore, it was classified as "Classification not possible."
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a teratogenicity study by the oral route (unknown) with rats, at a dose (8 mg/kg/day) where maternal toxicities (decreased body weight gain, decreased food consumption, piloerection and bloody nose secretion) were observed, effects on reproduction or fetuses (abortion (10 cases), increased early and total intrauterine death, decreased number of implantations, total live fetuses, fetal body weight and crown/rump length, increased non-ossification or weak ossification of the sternebrae and distended ureter) were observed, and in a teratogenicity study by the oral route (gavage) with rabbits, at the dose (1.0 mg/kg/day) indicating maternal toxicity (mortality (1/15 cases), decreased water consumption, decreased food consumption), reproductive or developmental effects (abortion, premature delivery, intrauterine death, vaginal hemorrhages, decreased number of implantations, decreased number of live fetuses, decreased fetal weight, decreased crown/rump length, decreased placental weight, omphalocele, delayed ossification) were observed (JMPR (1991)). In addition, triphenyltin compounds were reported to have effects on reproduction and development in experimental animals (CICAD 13 (1999)). Since the effects on reproduction were observed at doses that caused maternal toxicity as described above, this substance was classified in Category 2.
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	In humans, effects on the central nervous system such as headache, nausea, vomiting, dizziness, vision disorders, visual disturbances, loss of consciousness, and photophobia are observed (CICAD 13 (1999), HSDB (Access on July 2014)). In addition, hepatic injury was observed, and enlarged liver and increased liver aminotransferase activity were reported (HSDB (Access on July 2014)). No data are available for experimental animals. Moreover, although it is not data on this substance itself, the possibility of respiratory tract irritation as an organotin compound is described (ATSDR (2005), ACGIH 7th (2001)). From the above, it was classified in Category 1 (central nervous system, liver) and Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Category 1 (immune system)	Danger	H372	P260 P264 P270 P314 P501	No findings on toxic effects for repeated exposure in humans are available. As for experimental animals, as a result of feeding 15 ppm of this substance to guinea pigs for 47 and 77 days, at a dose corresponding to Category 1 (corresponding to 1.5 mg/kg/day (converted guidance value: 0.73-1.28 mg/kg/day)), decreases in thymus weight, decreases in the number of plasma cells of the spleen and lymph nodes were observed. Also, by feeding for 104 days, inhibition of the immunological reaction against tetanus toxoids was shown (CICAD 13 (1999), JMPR (1991)). In many studies in which triphenyltin hydroxide, a hydrolyzate of this substance in vivo, was administered by feeding to mice, rats, or dogs for 13 to 104 weeks, from a dose corresponding to Category 1, a decrease in the number of white blood cells and the number of lymphocytes and fluctuation of the immunoglobulin fraction (decrease in IgG and IgA, increase/decrease in IgM) were observed (CICAD 13 (1999), JMPR (1991)). From the above, since suppressive effects on the immune system were definitely observed in several animal species by repeated oral administration of this substance and the metabolite, it was classified in Category 1 (immune system).
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)	-	- -	-	-	-
11	Hazardous to the aquatic environment (Long-term)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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