NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	1309-64-4
Chemical Name	Diantimony trioxide
Substance ID	24B6523
Classification year (FY)	FY2012
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	FY2007 FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th 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 associated with explosive properties present in the molecule.
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 (2003)).
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 (2003)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2003)).
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))).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.
15	Organic peroxides	Not applicable	- -	-	-	It is not an organic 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 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.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	It is solid in the GHS definition, and no inhalation of gases is expected. Therefore, it was classified as "Not applicable."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
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.
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."
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Classification not possible	- -	-	-	No data available.
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.
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).
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.
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.
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).
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

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 3	- -	H402	P273 P501	It was classified in Category 3 from 72-hour EC50 = 67 mg/L for algae (Pseudokirchneriella subcapitata) (Chemical Substance Hazard Data (CERI, 2002)).
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	It was classified in Category 3 because it was classified in Category 3 in acute toxicity, and behavior in water and bioaccumulation of the metallic compound are unknown.
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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