NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	61790-53-2
Chemical Name	Diatomaceous earth [which contains 0.1% or more of Crystalline silica]
Substance ID	m-nite-61790-53-2a_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is not combustible (ICSC (2001)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is not combustible (ICSC (2001)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is not combustible (ICSC (2001)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound containing oxygen, but the classification is not possible due to no data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an inorganic compound.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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