GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 61790-53-2 |
| Chemical Name | Diatomaceous earth (uncalcined)/amorphous silica (diatomaceous earth (uncalcined)) |
| Substance ID | H27-A-041/C-112A_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 |
- |
- | - | Diatom earth comprises uncalcined one (CAS number: 61790-53-2), calcined one (CAS number: 91053-39-3), flux-calcined one (CAS number: 68855-54-9) and so on. Because there is reports such that uncalcined product, which is the target substance of this classification, contains 1-8% of crystalline silica (ACGIH (7th 2001), DFGOT vol. 2 (1991)), a case where crystalline silica of the similar content exists was supposed. 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 (ICSC (2001)). |
| 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 (ICSC (2001)). |
| 11 | Self-heating substances and mixtures | Not classified |
- |
- | - | It is non-flammable (ICSC (2001)). |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | Because there is the observation result of insoluble in water (HSFS (2007)), 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 |
- |
- | - | Diatom earth comprises uncalcined one (CAS number: 61790-53-2), calcined one (CAS number: 91053-39-3), flux-calcined one (CAS number: 68855-54-9) and so on. Because there is reports such that uncalcined product, which is the target substance of this classification, contains 1-8% of crystalline silica (ACGIH (7th 2001), DFGOT vol. 2 (1991)), a case where crystalline silica of the similar content exists was supposed. From a reported LD50 value of > 5,000 mg/kg for rats (Agricultural chemicals technology information (1992)), this substance was classified as "Not classified." |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | From a reported LD50 value of > 2,000 mg/kg for rabbits (Agricultural chemicals technology information (1992)), 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 |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | From the information that after 24-hour application of this substance in a skin irritation test using rabbits, no irritation was observed (Agricultural chemicals technology information (1992)), it was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that very slight irritation was observed but resolved by day two after application of 100 mg this substance in an eye irritation test using rabbits (Agricultural chemicals technology information (1992)), but it is judged to be insufficient information for the classification. |
| 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 |
- |
- | - | Due to lack of data, the classification is not possible. |
| 6 | Carcinogenicity | Category 1A |
 Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
There is the information that this substance contains 1 to 8% crystalline silica (ACGIH (7th, 2001)). Moreover, because it contains crystalline silica corresponding to Category 1A as a ratio of mixture composition in more than ten times of a cutoff value (0.1%) for Category 1 of carcinogenicity, this substance was classified in Category 1A in this hazard class. Besides, there is no carcinogenicity information for this substance in humans, and as for experimental animals, it is reported that tumor formation was not observed in a lifetime exposure test in rats in an oral route (in the diet) at a dose of 20 mg/animal and a test in mice subcutaneously injected (administration time not described) at a dose of 20 mg/animal (IARC 68 (1997)). On the other hand, it is reported that in a test in mice intraperitoneally injected (administration time not described) at 20 mg/animal, lymphosarcoma in the abdominal cavity was observed in 6/17, and a significant increase compared to a control group (1/20) was shown (IARC 68 (1997)). |
| 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 |
There is the information that this substance contains 1 to 8% crystalline silica (ACGIH (7th, 2001)). As for humans, there are reports of pneumoconiosis in workers exposed to diatom earth (DFGOT vol. 2 (1991)) and only mild silicosis observed in diatom earth workers exposed to uncalcined dust (ACGIH (7th, 2001)). Moreover, in a study in workers exposed to crude diatom earth or natural powders for 20 to 25 years, pulmonary fibrosis rarely occurred and if any, accompanied symptoms only without an apparent disability. It is reported that that natural diatom earth itself is either weakly fibrogenic or non-fibrogenic, and pulmonary fibrosis is considered to be attributed to crystalline silica or pulmonary overload (ACGIH (7th, 2001)). As for experimental animals, guinea pigs were exposed to 100 mg/m3 this substance in a 2-year inhalation exposure test. While for crystalline tested silica simultaneously, fibrosis was found after 21 months and became severe after 24 months, and for this substance, fibrosis was observed after 24 months, but there was no worsening (ACGIH (7th, 2001)). Besides, in a test in guinea pigs in 37 to 50-week inhalation exposure to 60mg/m3 this substance, thickening of the alveolar septa by infiltration of macrophages, accumulation of large numbers of multinuclear cells with dust particles, and epithelization of the alveoli were observed, but pulmonary fibrosis was not found. Moreover, a very slight increase was observed in reticular fibers, but no significant increase was found in collagen fibers (ACGIH (7th, 2001)). As above, this substance contains crystalline silica, and as for humans, in handling natural diatom earth, pulmonary fibrosis although rarely and pneumoconiosis although it is mild were reported. Moreover, as for experimental animals, effects on the lung were observed within a range of Category 2 although the severity is mild. Therefore, this 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) | Classification not possible |
- |
- | - | No data. |
| 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. |