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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	12172-73-5
Chemical Name	Amosite
Substance ID	H30-A-001-MHLW, MOE
Classification year (FY)	FY2018
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
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 (Ver. 1.1))
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 (GESTIS (Accessed Oct. 2018)).
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 (GESTIS (Accessed Oct. 2018)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (GESTIS (Accessed Oct. 2018)).
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Because there is an observation result that it is insoluble in water (GESTIS (Accessed Oct. 2018)), 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 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)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	[Rationale for the Classification] Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 based on (1) and (2). [Evidence Data] (1) This substance is one type of asbestos. Asbestos may directly induce genotoxicity by catalysing the generation of reactive oxygen species. Also, it is possible to physically interfere with the mitotic apparatus of the cell and this may result in aneuploidy of chromosomes and specific chromosomal alterations (IARC 100C (2012)). (2) As for in vitro, most of the chromosomal aberration tests and the sister chromatid exchange tests with human and mammalian cells, without metabolic activation were positive (ATSDR (2001)).
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 1A based on the data of human and experimental animals in (1), (2) and the classifications by other organizations in (3) and (4). [Evidence Data] (1) It is reported that lung cancer was observed in high-frequency among workers exposed to this substance (ATSDR (2001)), and that there is a correlation between the occupational exposure to this substance and the incidence of pleural and peritoneal mesothelioma. In addition, there are reports of increased incidence of gastrointestinal tract cancers in groups occupationally exposed to this substance (IARC 100C (2012)). (2) As for experimental animals, as a result of inhalation exposure to the standard sample of this substance with rats for two years, the incidence of thoracic tumors was 62%. In similar tests, the incidence of thoracic tumors with chrysotile and crocidolite were also 52% and 72% respectively (IARC 100C (2012)). (3) IARC concluded that there is sufficient evidence in humans for all carcinogenicity from six forms of asbestos (this substance, chrysotile, crocidolite, tremolite, actinolite, anthophyllite), based on (1), (2) and other experimental evidence (IARC 100C (2012)). (4) As for the classifications by other domestic and foreign organizations, it is classified in A1 by ACGIH (ACGIH (7th, 2001)). Also, asbestos is classified in Group 1by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (2018) proposed in 1981), as A by EPA (IRIS (1988)), as K by NTP (NTP RoC (14th, 2016)) and in Carc. 1A by EU CLP.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] There is a report that no effect on the fertility of parental animals was observed by diet administration, and that no malformation of offspring was observed as shown in (1). However, there is no description of general toxic effects on parental animals, so it is not possible to judge whether the dose to the parental animals is sufficient. In addition, there is no information on developmental toxicity tests with pregnant animals. Therefore, classification is not possible due to lack of data. [Evidence Data] (1) After dosing by feeding at up to 830 mg/kg/day to rats and hamsters during the gestation and lactation period, either adverse effects on the fertility of parental animals or malformations of offspring were not observed (ATSDR (2001)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] As for acute effects of this substance, there is no report on either humans or experimental animals. However, based on the test data of chrysotile (a related substance of this substance: both are one type of asbestos) in (1), it is considered that serious respiratory lesions such as pulmonary fibrosis occur as a delayed effect after a single inhalation exposure within the range of Category 1 in experimental animals, although the onset time is unknown. From the above, by applying the data of the related substance, this substance was classified in Category 1 (respiratory organs) as a medium to long-term effect from a single exposure. [Evidence Data] (1) There is a report that pulmonary fibrosis occurred as a result of inhalation exposure to chrysotile with mice for 5 hours at the concentration of 132 fibers/mL (equivalent to 4 mg/m3, converted 4-hour equivalent value: 0.005 mg/L) within the range of Category 1 (ATSDR (2001)). [Reference Data, etc.] (2) Although it is data for an other hazard class (carcinogenicity), as a result of single inhalation exposure to a standard sample (UICC) of this substance with rats for 7 hours at the concentration of 14.1 mg/m3 (converted 4-hour equivalent value: 0.025 mg/L) within the range of Category 1, thoracic tumors were observed in 4/45 rats (9%) (IARC 110C (2012)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] It was classified in Category 1 (respiratory organs) based on (1)-(3). [Evidence Data] (1) In many epidemiological research reports regarding occupational exposure, respiratory lesions derived from inhalation exposure to this substance or simultaneous exposure to this substance with crocidolite and chrysotile are reported. Findings of respiratory lesions include various reports from abnormalities of lung parenchyma detected by chest x-rays and pleura thickening, etc., or cases diagnosed as pulmonary fibrosis, to cases diagnosed as fatal asbestosis, or cases of chronic pharyngitis, and so on (ATSDR (2012)). (2) All types of asbestos are known to cause asbestosis, pleura changes and neoplastic lesions. However, based on the experimental and epidemiologic results, it is considered that there are differences in the potential of the different asbestos types to produce respiratory disease, and that crocidolite has the greatest potential, chrysotile has the smallest, and this substance occupies an intermediate position (ACGIH (7th, 2001)). (3) As for experimental animals, an increase in pulmonary fibrosis was observed as a result of inhalation exposure to this substance for one or two years with rats (ATSDR (2012)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] 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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

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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