GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 61790-53-2
Chemical Name Diatomaceous earth [which contains 0.1% or more of Crystalline silica]
Substance ID H29-B-086
Classification year (FY) FY2017
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 FY2015  
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

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - Diatomaceous earth includes uncalcined products (CAS RN 61790-53-2), calcined products (CAS RN 91053-39-3), flux-calcined products (CAS RN 68855-54-9), etc. The target of this classification was the uncalcined product containing not less than 0.1% of crystalline silica.

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 (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
-
-
- - Solid (GHS definition).
10 Pyrophoric solids Not classified
-
-
- - It is not combustible (ICSC (2001)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is not combustible (ICSC (2001)).
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 of being insoluble in water (HSFS (2007)).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition).
14 Oxidizing solids Classification not possible
-
-
- - It is an inorganic compound containing 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
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - Diatomaceous earth includes uncalcined products (CAS RN 61790-53-2), calcined products (CAS RN 91053-39-3), flux-calcined products (CAS RN 68855-54-9), etc. The target of this classification was the uncalcined product containing not less than 0.1% of crystalline silica.

Based on a report of an LD50 value of > 5,000 mg/kg for rats (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" (1992)), this substance was classified as "Not classified."
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a report of an LD50 value of > 2,000 mg/kg for rabbits (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" (1992)), this substance was classified as "Not classified."
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 Not classified
-
-
- - Based on a report that in a skin irritation test with rabbits, as the result of application of this substance for 24 hours, no irritation was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" (1992)), this substance was classified as "Not classified."
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Classification not possible due to lack of data. There is a report that in an eye irritation test with rabbits, as the result of application of 100 mg of this substance, very mild irritation was seen, but it resolved by day 2 (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" (1992)). However, it was judged as inadequate information for classification.
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 Classification not possible
-
-
- - Classification not possible due to lack of data.
6 Carcinogenicity Category 1A


Danger
H350 P308+P313
P201
P202
P280
P405
P501
Regarding crystalline silica, it was classified in Group 1 by IARC (IARC 100C (2012)), in K by NTP (NTP RoC (14th, 2016)), and in Group 1 by the Japan Society For Occupational Health (Recommendation of Occupational Exposure Limits (2016)), therefore, it was classified in Category 1A. Since this substance contains crystalline silica which corresponds to Category 1A not less than cut-off value (0.1%) of Category 1 for the carcinogenicity, it was classified in Category 1A.
Besides, regarding diatomaceous earth, there is no information on carcinogenicity in humans. As for experimental animals, there are reports that, in a lifetime study in which rats were dosed by oral route (feeding) at a dose of 20 mg/animal and in a test in which it was subcutaneously administered into mice at a dose of 20 mg/animal (the number of doses was not described), development of tumors was not observed (IARC 68 (1997)). On the other hand, there is a report that in a test in which it was intraperitoneally injected into mice at a dose of 20 mg/animal (the number of doses was not described), a development of lymphosarcoma in the abdominal cavity was observed in 6/17, and a significant increase compared to the control group (1/20) was shown. However, none of the test reports described the content of crystalline silica in the test substance (diatomaceous earth), and the presence or absence of crystalline silica was unknown (IARC 68 (1997)).
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.
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory organs)


Danger
H372 P260
P264
P270
P314
P501
As for humans, there are reports of pneumoconiosis in workers exposed to diatomaceous earth, however, it is reported that because exposure to other quartz dusts was unknown, cristobalite is produced due to calcination of diatomaceous earth, crystalline silica is contained in diatomaceous earth, etc., it is impossible to conclude that pneumoconiosis is due to diatomaceous earth (DFGOT vol. 2 (1991)). There is a report that only mild silicosis was observed in diatomite workers exposed to uncalcined dust (ACGIH (7th, 2001)). In addition, in a research on workers exposed to crude diatomaceous earth or natural powders for 20-25 years, it is rare to cause pulmonary fibrosis, if any, only symptoms and no demonstrable disability were observed. There is a report that it is assumed that natural diatomaceous earth itself is either weakly fibrogenic or nonfibrogenic and that lung fibrosis was due to crystalline silica or pulmonary overload (ACGIH (7th, 2001)).
As for experimental animals, in a test in which guinea pigs were exposed by inhalation for 2 years to 100 mg/m3 of diatomaceous earth as amorphous silica or to 150 mg/m3 of cristobalite as crystalline silica, in the case of cristobalite which is crystalline silica, fibrosis was observed after 21 months, and it became severe after 24 months, on the other hand, in the case of diatomaceous earth which is amorphous silica, fibrosis was observed after 24 months, and it did not become severe (ACGIH (7th, 2001)). In addition, in a test in which guinea pigs were exposed by inhalation for 37-50 weeks to 60 mg/m3 of uncalcined diatomaceous earth, 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. However, lung fibrosis was not observed, and an increase in very slight amount of reticulum fibers was observed, but no significant increase in collagen fibers was observed (ACGIH (7th, 2001)).
As above, for humans, effects of only diatomaceous earth not containing crystalline silica were not clear, but for diatomaceous earth containing crystalline silica, effects on the lungs can be expected. In addition, as for experimental animals, although the degree is slight, effects on the lungs were observed within the range of Category 2. This substance was classified in Category 1 (respiratory organs) since it contains crystalline silica.
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
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 available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible
-
-
- - No data available.
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.

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