NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	7631-86-9
Chemical Name	Silica (silicon dioxide containing crystalline and amorphous)
Substance ID	m-nite-7631-86-9_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)	- -	-	-	There are no chemical groups present in the molecule associated with explosive properties.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified	- -	-	-	It is non-flammable (NITE Chemical Risk Information Platform (Access on September 2015)).	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is non-flammable (NITE Chemical Risk Information Platform (Access on September 2015)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Not classified	- -	-	-	It is non-flammable (NITE Chemical Risk Information Platform (Access on September 2015)).	FY2015	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	- -	-	-	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Classification not possible	- -	-	-	It is an inorganic compound that contains oxygen, but the classification is not possible due to no data.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	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	- -	-	-	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2015	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	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	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	- -	-	-	Because physical property cannot be determined for a substance containing all silica forms, the classification is not possible at this time.	FY2015	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.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	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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