NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	1309-64-4
Chemical Name	Diantimony trioxide
Substance ID	m-nite-1309-64-4_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is stable toward water (water solubility 1.4 mg/100 mL (30 deg C) (ICSC (2003))).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is not an organic compound.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	In epidemiological cases in humans, mortality was observed (Chemical Substance Hazard Data 2001-7 (CERI, 2002)). Because concerns for acute health effects in humans are suggested, and death was seen in humans in certain circumstances, it was classified in Category 4.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	It is solid in the GHS definition, and no inhalation of gases is expected. Therefore, it was classified as "Not applicable."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	In the EU risk phrase (2005), irritation was assigned, but because supporting data are unknown, classification is not possible.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	The inter-ministerial committee on GHS classified it in Category 2B based on the test result of "mild irritation after administration of 100 mg to the rabbit eye" described in RTECS. On the other hand, it is mentioned in the literature in the public comment (LPT (2005)) that it was non-irritating in a test with rabbits by a GLP testing facility according to the OECD test guidelines. Therefore, one positive and one negative results exist in tests with rabbits. The literature of LPT (2005) was mentioned to be unpublicized in the public comment, but since it was available via general route, it was used for investigation in this project. The positive result in the former was from the test conducted in 1972, and the properties of the substance used and detailed signs are unknown. On the other hand, the latter test that gave a negative result was performed according to the OECD test guidelines in 2002, and the origin and properties of the substance and detailed symptoms seen were described. Therefore, it was considered that the latter with a negative result had superior credibility. And it was judged appropriate to change the classification of this substance from Category 2B to "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	From descriptions in PATTY (4th, 2000), Chemical Substance Hazard Data 2001-7 (CERI, 2002), IARC 47 (1989), there is no in vivo heritable germ cell mutagenicity test, an in vivo germ cell mutagenicity test (a chromosomal aberration test) was negative, and as for in vivo somatic cell mutagenicity test (a chromosomal aberration test), it was judged as negative (negative after a single dose; an incidence of chromosomal aberrations in the bone marrow increased after 21-day administration). Therefore, it was classified as "Not classified." Besides, the expert judgment was also "Not classified" (as a result of classification based on the information obtained by literature searches) and matched the above classification.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	It was classified in Category 1B because it was classified in A2 in ACGIH (2001).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	As reproductive/developmental toxicity tests for this substance (diantimony trioxide) itself, there are three tests, one for reproductive toxicity and two for developmental toxicity. As for reproductive toxicity, in a test in which female rats were exposed by inhalation for 1.5-2 months before mating, through mating (with untreated males), during a gestation period, by 3-5 days before delivery, decreased gestation rate and decreased litter size were seen, and adverse fertility effects were suggested. However, there are no data on the incidence of resorptions or fetal mortality, it is a test with only one dose (dust: 250 mg/m3), and the whole test conditions are unclear, including the fact that no morphological examination was done for the control group. And it is described that no conclusion could be drawn from the test because of unknown purity, particle size, etc. of the test substance, and the results could not be used for assessment (Initial Risk Assessment Report 132 (NITE, CERI, NEDO, 2008), EU-RAR (2008) DRAFT). On the other hand, as for developmental toxicity, in a test by inhalation exposure of rats during a gestation period (for 21 days), there were no effects on body weight changes in maternal animals, and an increase in pre and post-implantation intrauterine embryonic/fetal mortality was observed, but the test substance was reported to be just antimony oxide, and because of no report on purity, particle size, test conditions, etc. or information on the test substance, the test was judged as not conclusive (Initial Risk Assessment Report 132 (NITE, CERI, NEDO, 2008), EU-RAR (2008) DRAFT). It is reported that in the other developmental toxicity test (OECD TG 414), after inhalation exposure at 2.6-6.3 mg/m3, general toxicity was found in maternal animals while no developmental toxicity, including teratogenicity, was observed (EU-RAR (2008) DRAFT). However, due to the revision of GHS classification guidance for the Japanese government, the classification is not possible with the results alone. As described above, due to no data available for effects on sexual function/fertility in a reproductive toxicity test, it was classified as "Classification not possible" due to lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	As for the heart, because it was impossible to find the description that the inter-ministerial committee on GHS used as the rationale for classification in the source of the literature, it is appropriate to delete Category 1 (heart) from the classification. As for the respiratory system, as a result of judging after investigating the sources of Chemical Substance Hazard Data (CERI), which the inter-ministerial committee on GHS used as the rationale, it would be classified in Category 2. On the other hand, by classification based on the literature presented in the public comment, it would be classified as "Not classified." Either case used valuable data and lead to a different category, and it was judged appropriate to classify it in Category 2 for publicity purposes of the hazard. From the above, "Category 1 (heart), Category 2 (respiratory system) " was revised to "Category 2 (respiratory system)." Besides, the literature presented in the public comment in FY 2007 (LPT, 2005) was mentioned to be unpublicized in the public comment, but since it was available via general route, it was used for investigation in this project.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	As for humans, there are descriptions such as "chest X-ray revealed pneumonitis," "antimony pneumoconiosis was observed, and pneumoconiosis was suspected," "a correlation between the degree of radiographic abnormalities, amount of antimony retained in the lung, and duration of exposure was reported," "the presence of diffuse, densely distributed punctate opacities having a diameter < 1 mm and concentrated in the mid-lung region" (IRIS (2002)). As for experimental animals, there are descriptions such as "Necropsy revealed lung discoloration. Particle-laden macrophages, degenerative macrophages, and cellular debris in the lumen of the alveoli were observed," "interstitial fibrosis, alveolar cell hypertrophy and hyperplasia," "granulomatous inflammation and granuloma" (IRIS (2002)), "decreased body weight, interstitial fibrosis, alveolar cell hypertrophy and hyperplasia, cuboidal and columnar cell metaplasia, and cholesterol clefts in the lung" (Chemical Substance Hazard Data 2001-7 (CERI, 2002)). Therefore, the respiratory system and digestive system were considered to be the target organs. Besides, effects in experimental animals were found within the guidance value range for Category 1. From the above, it was classified in Category 1 (respiratory system).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	From 96-hour LC50 > 530 mg/L for fish (Lepomis macrochirus) (Initial Risk Assessment Report, NITE, 2008), 48-hour EC50 = 506 mg/L for crustacea (Daphnia magna) (Result of the initial environmental risk assessment of chemicals, Vol. 6, Ministry of the Environment in Japan, 2008), and 72-hour EC50 > 2.87 mg/L for algae (Pseudokirchneriella subcapitata) (EU-RAR, 2008), it was classified as "Not classified."	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to 33 to 35-day NOEC > 0.00898 mg/L for fish (Pimephales promelas) (Result of the initial environmental risk assessment of chemicals, Vol. 6, Ministry of the Environment in Japan, 2008; Initial Risk Assessment Report, NITE, 2008; EU-RAR, 2008) despite unknown environmental dynamics of an inorganic compound. If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it corresponds to "Not classified" in acute toxicity for both algae and crustacea and is not water-insoluble (water solubility = 2.76 mg Sb/L (pH 8, 22.2 degrees C prepared water, 7 days) (EU-RAR, 2008)). It was classified as "Not classified" from the above results.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2014	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.0))

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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