GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 14464-46-1 |
| Chemical Name | Crystalline silica (cristabolite) |
| Substance ID | H27-A-037/C-107A_P |
| Classification year (FY) | FY2015 |
| 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 |
| 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 present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Not classified |
- |
- | - | It is non-flammable (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 |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Not classified |
- |
- | - | It is non-flammable (GESTIS (Access on September 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is non-flammable (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 because there is the observation result of being insoluble in water (ACGIH (7th, 2001)). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an inorganic compound that contains 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 |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
As for in vivo, it is reported that a significant increase in mutation frequency was observed in a test using this substance to investigate hprt gene mutation of the alveolar epithelial cells after 13-week inhalation exposure to rats (SIDS (2013)). There is no in-vivo or in-vitro data other than that. From the above, although data are limited, the substance was classified in Category 2 in accordance with the Guidance. Besides, it is considered that genotoxicity by this substance is attributed to reactive oxygen species by the substance or by inflammatory cells by the substance (SIDS (2013), IARC 100C (2012)). |
| 6 | Carcinogenicity | Category 1A |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
In many epidemiological study results, a positive correlation between occupational exposure to crystalline silica including this substance and an increased risk of lung cancers were observed. Especially when multiple study results were pooled into different meta-analyses, relative risks were consistently and significantly increased (IARC100C (2012), SIDS (2013)). There is the comment that there is sufficient evidence of increased risk of lung cancers in humans in inhalation exposure to crystalline silica dust in the form of this substance (IARC 100C (2012)). On the other hand, as for experimental animals, rats received a single intrapleural injection of this substance 20 mg/body and were observed for life span. While a dosed group had an average survival of 597 days and showed malignant lymphomas of a histiocytic type in 4 (4/32), a control group had an average survival of 717 days and did not show tumors of the such type (0/32) (IARC 68 (1997), ACGIH (7th, 2006)). As above, from the carcinogenicity information in human and experimental animals, IARC classified it in "Group 1" as to human carcinogenicity by exposure to dust of this substance in 1997, and did not change the classification result in the reassessment in 2012 (IARC 68 (1997), IARC 100C (2012)). As to the classification results of carcinogenicity by other organizations, Japan Society for Occupational Health classified crystalline silica in "Group 1" (The Recommendation of the Japan Society for Occupational Health (2015)), ACGIH classified this substance in "A2" from 2004 onward (ACGIH (7th, 2006)), and NTP classified crystalline silica (respirable size) in "K" from 1991 onward (NTP RoC (13th, 2014)). Therefore, this substance was classified in Category 1A for this hazard class. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs) |
Danger |
H372 | P260 P264 P270 P314 P501 |
As for humans, silicosis is reported for this substance similarly to quartz. Besides, as for experimental animals, it is reported that the substance is more inflammatory and fibrogenic than alpha-quartz (ACGIH (7th, 2006)). Therefore, the substance was classified in Category 1 (respiratory organs). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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 24-hour LL50 > 10,000 mg/L for crustacea (Daphnia magna), and 96-hour LL0 = 10,000 mg/L for fish (Danio rerio) in test data using amorphous silica (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. Because it is an inorganic compound and appropriate data are not obtained on rapid degradability and bioaccumulation despite "Not classified" in acute toxicity, it was classified as "Classification not possible." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
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. |