GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 18972-56-0
Chemical Name Magnesium hexafluorosilicate hexahydrate
Substance ID H30-B-010-MHLW, MOE
Classification year (FY) FY2018
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 FY2006  
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
-
-
- - 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 (Hommel (1987)).
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 (Hommel (1987)).
11 Self-heating substances and mixtures Not classified
-
-
- - It is not combustible (Hommel (1987)).
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - Because there is a measurement result of water solubility: 60 g/100 g (Hommel (1987)), it is estimated that it does not react vigorously with water.
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition)
14 Oxidizing solids Classification not possible
-
-
- - It is an inorganic compound containing halogen (F) (but not 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) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 3.

[Evidence Data]
(1) LD50 for rats: 291 mg/kg (REACH registration dossier (Accessed Aug. 2018)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - [Rationale for the Classification]
Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
Based on (1), it was classified in Category 4. The category was changed by adopting the REACH registration dossier.

[Evidence Data]
(1) LC50 (4 hours) for rats: 3.6 mg/L (REACH registration dossier (Accessed Aug. 2018)).
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Although human and animal test data are not available, reliable in vitro data (1) indicate Category 3. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification). Besides, the category was changed from the previous classification by using new information.

[Evidence Data]
(1) There is a report that in an in vitro study (OECD TG 439 (reconstituted human epidermis test method), GLP-compliant), in which this substance was applied to human epidermis cells for 15 minutes, at the time of observation after 42 hours, no irritation was observed (REACH registration dossier (Accessed Aug. 2018)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
[Rationale for the Classification]
Although human and animal test data are not available, it was classified in Category 1 based on reliable in vitro data (1). Besides, the category was changed from the previous classification by using the new information.

[Evidence Data]
(1) There is a report that since in an in vitro test (OECD TG 437 (Bovine Corneal Opacity and Permeability (BCOP) test), GLP-compliant), in which a 20% solution of this substance was applied to isolated bovine corneas for 4 hours, in vitro irritancy score (IVIS) of 109.3 (IVIS of 64.8 for positive control) was obtained, this substance shows serious damage to the eyes (REACH registration dossier (Accessed Aug. 2018)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Information (1) indicating that this substance is not a skin sensitizer is also obtained, however, not enough evidence to determine "Not classified" is obtained, therefore, it was classified as "Classification not possible." Besides, the category was changed from the previous classification by using new information.

[Evidence Data]
(1) There is a report that this substance was not sensitizing in an LLNA test (OECD TG 442B, GLP test) with mice (REACH registration dossier (Accessed Aug. 2018)).
5 Germ cell mutagenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) There was a negative result in a bacterial reverse mutation test with disodium hexafluorosilicate (CAS RN: 16893-85-9) instead of this substance (REACH registration dossier (Accessed Aug. 2018)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) There are reports that in a three-generation reproductive toxicity study with rats and developmental toxicity studies with pregnant rats and rabbits in which a related substance, sodium fluoride (CAS RN: 7681-49-4), was administered as the test substance by drinking water, reproductive and developmental effects which should be evidence of the classification were not observed (REACH registration dossier (Accessed Aug. 2018)).
8 Specific target organ toxicity - Single exposure Category 2 (nervous system, respiratory organs), Category 3 (narcotic effects)



Warning
H371
H336
P308+P311
P260
P264
P270
P405
P501
P304+P340
P403+P233
P261
P271
P312
[Rationale for the Classification]
Based on (1), since symptoms of the nervous system such as twitching and trembling and anesthesia were observed within the range of Category 2, it can be classified in Category 2 (nervous system), Category 3 (narcotic effects). In addition, based on (2), it can be classified in Category 2 (respiratory organs) because flatulence was observed at doses within the range of Category 2. Therefore, it was classified in Category 2 (nervous system, respiratory organs), Category 3 (narcotic effects).

[Evidence Data]
(1) There is a report that in a single oral administration test with rats, apathy, staggering, cyanosis, diarrhea, twitching, trembling, rattling, dyspnoea, anesthesia, etc. were observed at 316-1,000 mg/kg/day (within the range of Category 2) (REACH registration dossier (Accessed Aug. 2018)).
(2) In a single inhalation exposure test (4 hours) with rats, at 1.07-4.16 mg/L (within the range of Category 2), discharge of the eye and nose, and reddish encrusted nose as irritation symptoms to the nose were observed. Other than these, dyspnoea, staggering gait, apathy, and in the dead animals, flatulence, etc. were observed (REACH registration dossier (Accessed Aug. 2018)).
9 Specific target organ toxicity - Repeated exposure Category 1 (teeth, bone)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1 (teeth, bone). In (2), there are descriptions that the teeth, bone and kidneys are target organs, and that findings on the teeth and bone indicated typical fluorosis. However, since no histopathological abnormalities were observed in the kidney, this was judged to be excluded from target organs. Besides, a target organ was newly added by adopting new information sources.

[Evidence Data]
(1) In humans, bone lesions associated with fluorosis due to occupational exposure to inorganic fluoride are reported (ACGIH (7th, 2001)).
(2) There is a report that in a test with rats dosed by feeding, pronounced impairment of enamel of the incisors at or above 900 ppm (converted value: 14 mg/kg/day, within the range of Category 2), and teeth whitening and increased BUN at 3000 ppm (converted value: 46.7 mg/kg/day, within the range of Category 2) were observed (REACH registration dossier (Accessed Aug. 2018)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
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:
  • 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.

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