NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	14808-60-7
Chemical Name	Crystalline silica (quartz)
Substance ID	m-nite-14808-60-7_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (GESTIS (Access on September 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It is estimated that it does not react vigorously with water from the observation result that it is insoluble in water (ICSC (2010)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic substance containing oxygen, but the classification is not possible due to no data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic substance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, an hprt gene mutation test with alveolar epithelial cells of rats dosed by intratracheal instillation was positive, an hprt gene mutation test with the lung tissue of mice was negative though the method of administration was not specified, a micronucleus test with mice dosed intraperitoneally was negative, a chromosomal aberration test and a sister chromatid exchange test with human lymphocytes were positive though exposure methods were not specified, oxidative DNA damage tests with the lung and peripheral blood of rats were positive or negative, and DNA strand break tests with the epithelial lung cells of rats were positive (SIDS (2013), CICAD 24 (2000), DFGOT Vol. 14 (2000), IARC 68 (1997)). As for in vitro, mammalian cell gene mutation tests gave positive and negative results, micronucleus tests with mammalian cultured cells gave positive and negative results, and chromosomal aberration tests and sister chromatid exchange tests with mammalian cultured cells were negative (SIDS (2013), CICAD 24 (2000), DFGOT Vol. 14 (2000), IARC 68 (1997)). From the above, this substance was classified in Category 2 in accordance with the GHS classification guidance for the Japanese government. Besides, the genotoxicity of this substance is thought to be attributable to reactive oxygen species derived from this substance or from the inflammatory cells caused by this substance (SIDS (2013), IARC 100C (2012)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1A	Danger	H350	P308+P313 P201 P202 P280 P405 P501	In the results of many epidemiological studies, a positive correlation between occupational exposure to crystalline silica containing this substance (quartz) and an increased risk of lung cancer was found. Also, in particular, even when the results of multiple studies were pooled, and different meta-analyses were conducted, a significant increase in the relative risk was shown consistently (IARC 100C (2012), SIDS (2013)). Accordingly, it is described that there is sufficient evidence for an increased risk of lung cancer in humans by inhalation exposure to crystalline silica dust with the shape of this substance (quartz) (IARC 100C (2012)). Meanwhile, in experimental animals, in a 2-year test in which female and male rats were exposed by inhalation to 1 mg/m3 of this substance (mass median aerodynamic diameter (MMAD): 1.3 micrometers), and in a 83-week test in which female rats were exposed by nose inhalation to 12 mg/m3 of this substance (MMAD: 2.24 micrometers), significant increases in lung tumors were observed in the exposed group, and there were many adenocarcinomas as the histological type. Furthermore, also in a study in which female rats were exposed by nose inhalation to 6.1 and 30.6 mg/m3 of this substance (MMAD: 1.8 micrometers), a dose-dependent increase in lung tumors was observed, and squamous cell carcinoma was the most common in the histological type, and bronchiolo/alveolar epithelial carcinomas or adenomas were often observed (IARC 100C (2012)). From the above, based on information on carcinogenicity in humans and experimental animals, in 1997, IARC classified it in Group 1 with regard to carcinogenicity in humans due to exposure to the dust of this substance, and even in a reevaluation in 2012, the classification result was not changed (IARC 68 (1997), IARC 100C (2012)). As for results of carcinogenicity classifications by other organizations, Japan Society for Occupational Health classified it in Group 1 (Recommendation of Occupational Exposure Limits (2015)), ACGIH has classified it in A2 since 2004 (ACGIH (7th, 2006)), and NTP classified Crystalline Silica (Respirable Size) as K (NTP RoC (13th, 2014)). Therefore, it was classified in Category 1A for this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the data on effects on the human respiratory organs used in the previous classification was short-term exposure data and not data on single-dose acute effects.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs, immune system, kidney)	Danger	H372	P260 P264 P270 P314 P501	In humans, in many epidemiological studies, effects on the respiratory organs (silicosis, lung cancer, pulmonary tuberculosis) due to occupational exposure to this substance were found. In addition, autoimmune diseases (scleroderma, rheumatoid arthritis, polyarthritis, mixed connective tissue disease, systemic lupus erythematosus, Sjogren's syndrome, polymyositis, fibrositis), chronic renal disease, and subclinical renal changes were also observed (SIDS (2013), CICAD 24 (2000), DFGOT vol. 14 (2000)). These kidney diseases are thought to be related to autoimmunity (SIDS (2013)). Likewise in experimental animals, fibrosis in the lung was found in repeated inhalation exposure tests with rats (SIDS (2013)). Therefore, it was classified in Category 1 (respiratory organs, immune system, kidney).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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 the test data on amorphous silica of 24-hour LL50 > 10,000 mg/L for crustacea (Daphnia magna) and 96-hour LL0 = 10,000 mg/L for fish (Danio rerio) (both SIDS, 2013), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Reliable chronic toxicity data were not obtained. Although it is classified as "Not classified" in acute toxicity, because data on rapid degradability and bioaccumulation were not obtained as an inorganic compound, it was classified as "Classification not possible."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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