GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 7631-86-9 |
| Chemical Name | Silica (silicon dioxide containing crystalline and amorphous) |
| Substance ID | H27-A-043/C-114A_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 (NITE Chemical Risk Information Platform (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 (NITE Chemical Risk Information Platform (Access on September 2015)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is non-flammable (NITE Chemical Risk Information Platform (Access on September 2015)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | Because there is the observation result of insoluble in water (NITE Chemical Risk Information Platform (Access on September 2015)), it is estimated that it does not react vigorously with water. |
| 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) | Not classified |
- |
- | - | This substance is a generic term for silica dioxide including crystalline and amorphous. [Besides, please refer to calssificatino results of the following substances for health hazards: crystalline silica (quartz) (CAS number: 14808-60-7), crystalline silica (cristobalite) (CAS number: 14464-46-1), crystalline silica (tripoli) (CAS number: 1317-95-9), crystalline silica (tridymite) (CAS number: 15468-32-3), amorphous silica (silica gel, precipitated silica) (CAS number: 112926-00-8), amorphous silica (diatom earth (uncalcined)) (CAS number: 61790-53-2), amorphous silica (quartz glass) (CAS number: 60676-86-0), amorphous silica (fumes), silica fumes ( a by-product in producing metal silicone) (CAS number: 69012-64-2)] There are 8 reported LD50 value for rats of > 3,160 mg/kg (EPA pesticide (1991)), > 3,300 mg/kg (hydrophilic calcined silica), > 2,000 mg/kg (hydrophobic calcined silica), > 5,000 mg/kg (3 for hydrophobic calcined silica, 1 for hydrophilic precipitated silica, total 4), > 5,110 mg/kg (hydrophilic precipitated silica) (ECETOC JACC (2006), SIDS (2006)). This substance was classified as "Not classified" to which most of the data (7) correspond. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From reported LD50 values of > 2,000 mg/kg (silica gel) and > 5,000 mg/kg (precipitated silica) for rabbits (ECETOC JACC (2006), SIDS (2006)), it was classified as "Not classified." |
| 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 |
- |
- | - | The classification is not possible due to lack of data. There are LC50 values (4 hours) for hydrophilic silica of > 0.691 mg/L (ECETOC JACC (2006)) and > 2.08 mg/L (ECETOC JACC (2006), SIDS (2006)) for rats, and 8 reported LC50 values (4 hours) for hydrophobic silica of 0.09 mg/L, 0.09 to 0.84 mg/L, 0.45 mg/L, 0.5 mg/L, 0.6 mg/L, 0.8 mg/L, 1.65 mg/L, and > 2.22 mg/L f or rats, 10 reports in total (ECETOC JACC (2006)). Because it is written in in the main text of ECETOC JACC (2006) that deaths observed in hydrophobic silica were not due to toxicity but to suffocation by administration of test substance particles at high concentrations, it was not adopted for the classification. The category cannot be determined only from 2 pieces of information in hydrophilic silica. Besides, a reference value of dust and mists was applied because test substance is a solid. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that irritation was not observed after application of precipitated silica (CAS number: 112926-00-8) in a skin irritation test using rabbits (OECD TG 404) (SIDS (2006), ECETOC JACC (2006)). Besides, it is reported that irritation was not found in a test in which precipitated silica or amorphous silica (CAS number: 112945-52-5) having a different form was applied respectively to rabbits for 24 hours (SIDS (2006), ECETOC JACC (2006)). From the above, this substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2 |
 Warning |
H319 | P305+P351+P338 P337+P313 P264 P280 |
It is reported that irritation was not observed after application of precipitated silica (CAS number: 112926-00-8) in an eye irritation test using rabbits (OECD TG 405) (SIDS (2006), ECETOC JACC (2006)). Besides, there are multiple reports from tests in which precipitated silica or amorphous silica (CAS number: 112945-52-5) having a different form was applied to rabbits, including no eye irritation found and the one in which slight conjunctivitis, slight to moderate conjunctival redness and corneal opacity were observed, but all signs were reversible (SIDS (2006), ECETOC JACC (2006)). From the above, this substance was classified in Category 2. |
| 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 | Classification not possible |
- |
- | - | Because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government, it was classified as "Classification not possible." As for in vivo, a dominant lethal test in oral administration in rats and a chromosomal aberration test in rat bone marrow cells after oral administration were negative (ECETOC JACC (2006), SIDS (2006)). As for in vitro, a bacterial reverse mutation test, a gene mutation test and a chromosomal aberration test in cultured mammalian cells were negative, and a micronucleus test in cultured mammalian cells was weakly positive (ECETOC JACC (2006), SIDS (2006)). |
| 6 | Carcinogenicity | Category 1A |
 Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
A group of substances which this CAS number indicates are silica (SiO2), and all forms of silica are included (ECETOC JACC No. 51 (2006)). Because a group of this substance includes crystalline silica, whose classification result for carcinogenicity is considered to be applicable, 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 | Category 3 (Respiratory tract irritation) |
Warning |
H335 | P304+P340 P403+P233 P261 P271 P312 P405 P501 |
From the information that silica gel (CAS number: 112926-00-8) is irritating to the respiratory tract (SIDS (2006), ECETOC JACC (2006)), it was classified in Category 3 (respiratory tract irritation). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (respiratory organs, immune system, kidney) |
Danger |
H372 | P260 P264 P270 P314 P501 |
As for humans, silicosis was reported in quartz and cristobalite. Moreover, also in experimental animals, it is reported that quartz and cristobalite have fibrogenic property. Other than that, autoimmune disease, chronic kidney disease, and asymptomatic kidney degeneration in quartz and recurrent fever like metal fume fever in molten silica are reported (ACGIH (7th, 2006)). Therefore, this substance was classified in Category 1 (respiratory organs, immune system, kidney). |
| 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) | Classification not possible |
- |
- | - | Because physical property cannot be determined for a substance containing all silica forms, the classification is not possible at this time. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data. |
| 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. |