GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 112926-00-8 |
| Chemical Name | Amorphous silica (silica gel, precipitated silica) |
| Substance ID | H27-A-040/C-111A_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 |
- |
- | - | This substance is a substance within a range limited to amorphous silica, but information was not obtained. Because data of non-flammable were obtained for CAS number: 7681-86-9 including crystalline and amorphous (GESTIS (Access on September 2015)), it was classified as "Not classified." |
| 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 |
- |
- | - | This substance is a substance within a range limited to amorphous silica, but information was not obtained. Because data of non-flammable were obtained for CAS number: 7681-86-9 including crystalline and amorphous (GESTIS (Access on September 2015)), this substance was classified as "Not classified." |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | This substance is a substance within a range limited to amorphous silica, but information was not obtained. Because data of non-flammable were obtained for CAS number: 7681-86-9 including crystalline and amorphous (GESTIS (Access on September 2015)), this substance was classified as "Not classified." |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | This substance is a substance within a range limited to amorphous silica, but information was not obtained. Because there is the observation result of insoluble in water for CAS number: 7681-86-9 including crystalline and amorphous (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 |
- |
- | - | From reported LD50 values of > 5,000 mg/kg (precipitated silica (Tixosil 53)) and > 5,110 mg/kg (precipitated silica (Sident9)) for rats (SIDS (2006), ECETOC JACC (2006)), it was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From reported LD50 values of > 2,000 mg/kg (silica gel (Syloid 244)) and > 5,000 mg/kg (silica gel (ZEO 49, ZEOSYL 113, ZEOSYL 200, and ZEOFREE 153)) for rabbits (SIDS (2006), ECETOC JACC (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. Besides, the category cannot be determined only from reported LC50 values (4 hours) of > 0.691 mg/L (precipitated silica (SIPERNAT 22S)) (ECETOC JACC (2006)) and > 2.08 mg/L (amorphous silica (CAB-O-SIL M5)) for rats (SIDS (2006)). Because test substance is a solid, a reference value of dust and mists was applied. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | It is reported that in a skin irritation test using rabbits (OECD TG 404), irritation was not reported after application of precipitated silica (Sident9) (SIDS (2006), ECETOC JACC (2006)). Moreover, it is reported that irritation was not observed in a test applied precipitated silica (SIPERNAT) in rabbits for 24 hours (SIDS (2006), ECETOC JACC (2006)). Besides, it is reported that irritation was not found after 24-hour application of silica gel (Syloid 244) in rabbits (SIDS (2006)). From the above, the substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 | P305+P351+P338 P337+P313 P264 |
It is reported that in an eye irritation test using rabbits (OECD TG 405), after application of precipitated silica (Sident9), slight conjunctival redness was seen but resolved (SIDS (2006), ECETOC JACC (2006)). Besides, there are multiple reports from tests by application of precipitated silica to rabbits such that no eye irritation was observed and that slight conjunctival irritation was found but resolved (SIDS (2006)). From the above, it was classified in Category 2B. |
| 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, a gene mutation test, and a chromosomal aberration test after oral administration or inhalation exposure in rats were all negative (SIDS (2006)). As for in vitro, a bacterial reverse mutation test, and a gene mutation test and a chromosomal aberration test in cultured mammalian cells were negative, and a micronucleus test in cultured mammalian cells gave an ambiguous result (SIDS (2006)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | This substance is classified in synthetic amorphous silica (IARC 68 (1997)). There is no information on carcinogenicity by exposure to synthetic amorphous silica to humans. However, from the insufficient evidence of carcinogenicity in humans for the whole synthetic amorphous silica (including diatom earth and biogenic silica fibers other than this substance) and insufficient evidence also in experimental animals for synthetic amorphous silica (described below), IARC classified the whole amorphous silica in "Group3" in carcinogenicity (IARC 68 (1997)). Therefore, this substance was also classified as "Classification not possible" according to the IARC evaluation. Besides, as human carcinogenicity related information on amorphous silica, it is reported that in a case-control study targeted for three communities exposed to biogenic amorphous silica fibers, the association between exposure to silica and mesothelioma formation was not observed (IARC 68 (1997)). On the other hand, as for experimental animals, 1-year inhalation exposure to this substance or ferric oxide alone, or a 1:1 mixture of both at a dose of 500 mg/body in rats resulted in little difference between a survival rate a control group and that of a dosed group. Moreover, in animals surviving 10 months or more, the incidence of lung tumors (adenoma, cancer) were 7.9 to 9.6% in a control group (5/53 to 5/52), 21.3% in a group administered this substance only (13/61), 32.7% in a group administered ferric oxide only (17/52), and 19.3% in a group administered a mixture (12/62) (IARC 68 (1997)). On the other hand, as carcinogenicity related information in an oral route, it is written that in 2-year diet administration of synthetic amorphous silica gel (Syloid 244) in rats or mice, neoplastic or non-neoplastic change was not observed in principal organs at the doses up to 50,000 ppm (ECETOC JACC (2006), IARC 68 (1997)). |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no information on reproductive effects in humans. As for experimental animals, it is reported that in a teratogenicity test in pregnant female animals of rats, mice, hamsters, and rabbits in gavage administration of synthetic amorphous silica (Syloid 244) during an organogenetic period, maternal toxicity, fetal toxicity, or teratogenicity was not observed in any animal species even administered at the doses from 1,340 to 1,600 mg/kg/day (ECETOC JACC (2006)). However, because there is no test report on effects on sexual function and fertility by administration of this substance, and this substance was classified as "Classification not possible" for this hazard class due to lack of data. |
| 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 report that silica gel (Syloid 244) 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 | Classification not possible |
- |
- | - | As for humans, it is reported that adverse effects were not observed in pulmonary function and chest radiography in workers who had been exposed to dust of this substance for an average of 8.5 years. (ACGIH (7th, 2001), ECETOC JACC (2006), SIDS (2006), DFGOT vol. 2 (1991)). As for experimental animals, it is reported that pulmonary fibrosis was not observed in an inhalation exposure test in rats, guinea pigs, and rabbits at 126 mg/m3 this substance for 1 year for rats and 2 years for guinea pigs and rabbits, and the reaction was limited to macrophage accumulations and mild proliferation of reticular fibers (ACGIH (7th, 2001)). In a 21-month diet administration test using mice and a 24-month diet administration test using rats, toxic effects were not observed (ECETOC JACC (2006)). It is reported that in a 12 to 18-month inhalation exposure test at 15 mg/m3 this substance in monkeys, rats, and guinea pigs, an increase in mononuclear cells and increased reticular fibers in the lung were observed (DFGOT vol. 2 (1991)). As above, effects were not shown in humans, and in experimental animals, only slight effects were observed in an inhalation route, and no effects were found in an oral route. Therefore, the substance was classified as "Classification not possible." |
| 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 EC50 > 10000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 = 10000 mg/L for fish (Danio rerio) (both SIDS, 2006), 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. |