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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	7783-47-3
Chemical Name	Stannous fluoride
Substance ID	H26-B-060, -
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	Not classified	- -	-	-	It is not combustible (ICSC (2004)).
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 not combustible (ICSC (2004)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2004)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Because data of water solubility of 300 g/L (20 deg C) (ICSC (2004)) 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	- -	-	-	It is an inorganic compound containing halogen (but not oxygen), but the classification is not possible due to no data.
15	Organic peroxides	Not applicable	- -	-	-	It is an inorganic compound.
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 2	Danger	H300	P301+P310 P361+P364 P264 P270 P321 P330 P405 P501	Based on the report of an LD50 value for rats of 45.7 mg/kg (IARC 27 (1982), HSDB (Access on July 2014)), the substance was classified in Category 2. An information source with a higher priority (IARC 27 (1982)) was added and the category was revised.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that in a skin irritation test with rabbits, although no skin irritation occurred when a 0.5% aqueous solution was applied to the intact skin for 18 hours, in the case of abraded skin, polymorphonuclear leukocyte infiltration occurred when a 0.1% aqueous solution was applied, and pustule development and destruction of the epidermis occurred when a 0.25% aqueous solution was applied (CICAD 65 (2005)). In addition, there is a report that no irritation was observed when a 0.1% solution of this substance was applied to the skin of rabbits (DFGOT vol. 14 (2000)).
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, although there is a description that this substance is irritating to the eyes (ICSC (2004)) in the information of List 3, the details of the information source etc. are unknown, therefore, these data were judged insufficient for use in classification. The information was updated and the category was changed according to the revision of the GHS classification guidance for the Japanese Government.
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	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a micronucleus test with mice bone marrow cells, and as for in vitro, it was negative in a bacterial reverse mutation test (CICAD 65 (2005)).
6	Carcinogenicity	Classification not possible	- -	-	-	There is no classification of carcinogenicity for this substance by international evaluation organizations. Besides, fluoride is classified in Group 3 by IARC (CICAD 65 (2005), HSDB (Access on July 2014)), and is classified in A4 by ACGIH (HSDB (Access on July 2014), ACGIH (2001)). However, in IARC and ACGIH, inorganic tin compounds are not evaluated and also carcinogenicity of stannous fluoride is not evaluated. From the above, it was classified as "Classification not possible" due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	There is a report that in a developmental toxicity test with rats by the oral route (feeding), there is no description of maternal animal toxicity, however, no effects on the number of litters and fetal resorption, placental weight, fetal body weight and the number of surviving fetuses were observed (CICAD 65 (2005), ATSDR (2005)). However, the number of animals used in this study is small as 9-10 animals, and the information on the fertility test is not available, therefore it was classified as "Classification not possible."
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	On the basis that inorganic tin compounds are irritating to the mucous membranes (ATSDR (2005)), it was classified in Category 3 (respiratory tract irritation).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Information on the effects of repeated exposure to this substance was not obtained from the information sources in List 1, and the following information was obtained from the HSDB of List 2. In humans, there are case reports that teeth staining or pigmentation considering to be the hypocalcification of enamel were observed by topical application of the solution or the gel of this substance to the teeth, and that the plaque index scores in children who used toothpaste containing 0.1% of the substance for 4 months decreased (HSDB (Access on July 2014)). In addition, although it is not a direct specific finding for this substance, based on the description that the effects of chronic excessive ingestion of fluorine are generally osteosclerosis and mottled enamel (HSDB (Access on July 2014)), effects on bone and teeth due to fluorine are suggested. However, since the hazard severity and the specificity as to effects by exposure to this substance are not necessarily high, it was judged that the evidence is currently insufficient to identify bone and teeth as target organs of repeated exposure to this substance. Besides, there is a report that in a test with rats administered 20 ppm in drinking water, ameloblasts were observed in the incisors after 6 months, but the effect was milder than sodium fluoride (HSDB (Access on July 2014)). In experimental animals, there is also no information on repeated administration of this substance other than this report. From the above, because there is no evidence suggesting a clear harmful effect by repeated exposure to this substance, classification was not possible due to lack of data.
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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