GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 14808-60-7 |
| Chemical Name | Crystalline silica (quartz) |
| Substance ID | H27-B-071/C-108B_P |
| Classification year (FY) | FY2015 |
| 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 | FY2014 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 (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 |
| 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 (Access on September 2015)). |
| 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 (Access on September 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is not combustible (GESTIS (Access on September 2015)). |
| 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)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic substance containing oxygen, but the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an inorganic substance. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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 | 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)). |
| 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. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (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." |
| 11 | Hazardous to the aquatic environment (Long-term) | 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." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |