GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 822-16-2
Chemical Name Sodium stearate
Substance ID R03-B-033-METI
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)
New/Revised Revised
Classification result in other fiscal year FY2014   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 (FY2019 revised edition (Ver. 2.0))
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 classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - No data available. Besides, there is information that it is combustible, and there is a risk of a dust explosion (GESTIS (Accessed Aug. 2021)).
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.
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Classification not possible
-
-
- - No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - It contains a metal (Na), but it is estimated that it does not react vigorously with water from information that it is soluble in water (GESTIS (Accessed Aug. 2021)).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine). The oxygen is chemically bonded to the element other than carbon or hydrogen (Na), but it is ionically bonded and does not contribute to oxidization.
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data, etc.]
(1) LD50 for rats: > 5,000 mg/kg (CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019))

[Reference Data, etc.]
(2) LD50 of stearic acid (CAS RN: 57-11-4) for rats: > 5,000 mg/kg (OECD TG 401) (SIAP (2014))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
No data available.

[Reference Data, etc.]
(1) LD50 of stearic acid (CAS RN: 57-11-4) for rabbits: > 2,000 mg/kg (REACH registration dossier (Accessed Sep. 2021))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
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) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that, in a skin irritation test with rabbits, this substance was non-irritating (ACGIH (7th, 2017), CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019)).

[Reference Data, etc.]
(2) It was reported that, in a 24-hour patch test with a 0.5% aqueous solution of this substance, 4 out of 20 subjects demonstrated minimal to moderate erythema (CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified." Also, based on the new findings, the category was changed.

[Evidence Data]
(1) It was reported that, in an eye irritation test with rabbits in stearic acid (CAS RN 57-11-4), mild conjunctival erythema was shown in 2 of 6 animals at 24 and 48 hours after application, but all effects subsided completely within 72 hours (REACH registration dossier (Accessed Sep. 2021)).
(2) It was reported that, in an eye irritation test with rabbits, this substance was minimal to mild irritant (CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019)).
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]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) It was reported that a 0.3% to 0.75% aqueous solution of this substance caused no sensitization in 100 subjects (CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
There was no data available on this substance, but based on the negative findings in various tests of magnesium stearate and stearic acid in (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) Since magnesium stearate (CAS RN 557-04-0) was negative in an in vitro bacterial reverse mutation test and an in vitro chromosomal aberration test using the Chinese hamster lung cells (CHL/IU) and it was negative in an in vivo micronucleus test using the bone marrow cells of mice, it was judged to have no genotoxicity of particular concern to living organisms (Risk Assessment Report (Food Additive) (Food Safety Commission of Japan, 2016)).
(2) When magnesium stearate is orally ingested, it is thought to partially dissociate into magnesium ion and stearic acid in the stomach (Risk Assessment Report (Food Additive) (Food Safety Commission of Japan, 2016)).
(3) It was reported that, in an in vitro bacterial reverse mutation test, stearic acid (CAS RN 57-11-4) was negative (CIR Expert Panel (2019), Risk Assessment Report (Food Additive) (Food Safety Commission of Japan, 2008)).

[Reference Data, etc.]
(4) This substance is soluble in water and magnesium stearate is insoluble in water (ACGIH (7th, 2017)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
There was no data available on this substance, but it was classified as "Not classified" based on the classification results by other organizations for sodium stearate and other stearates in (1) and the negative findings in various tests for magnesium stearate and stearates in (2) to (4).

[Evidence Data]
(1) As for the classification results by domestic and international organizations, the ACGIH classified stearic acid in A4 (ACGIH (7th, 2017)).
(2) In studies conducted in animals to assess the carcinogenic potential of stearates, either equivocal results which could not be determined to be positive or negative or negative results were obtained (ACGIH (7th, 2017)).
(3) In a 209-day feeding test with rats, no increase in tumors was observed in a group treated with stearic acid at 0.3% (3,000 ppm) (ACGIH (7th, 2017)).
(4) In a test with mice dosed by feeding stearic acid of up to 50 mg/kg/day (duration not reported), no carcinogenicity was observed (CIR Expert Panel (2019)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data. Also, since (2) was a screening test, it was not possible to judge if this substance had no reproductive toxicity.

[Evidence Data]
(1) Magnesium stearate (CAS RN 557-04-0) was not considered teratogenic in rabbits (ACGIH (7th, 2017)).
(2) In a reproductive toxicity screening study using calcium stearate (CAS 1592-23-0) as a test substance with rats dosed by gavage (28 days (males), from 14 days prior to mating until lactation day 3 (females)), no adverse effects were observed in either parental animals or offspring up to the limit level of 1,000 mg/kg/day (CIR Expert Panel (Experts Panel, Cosmetic Ingredient Review, 2019)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient toxicity information available for classification in the other routes.

[Evidence Data]
(1) It was reported that, in an oral toxicity study with rats, no toxicity was observed at doses up to 5,000 mg/kg (in the range corresponding to "Not classified") (CIR Expert Panel (2019)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) In a case of a rubber worker who had been occupationally exposed to zinc stearate (CAS RN: 557-05-1) dust for 29 years used as a mold release agent, pneumoconiosis developed and histological examination showed an increase in connective tissue and chronic inflammation in the lung. In addition, numerous granules and needles in the fibrotic tissue that contained zinc were found at autopsy (ACGIH (2017)).
(2) In a case of pulmonary fibrosis in a worker who had been exposed to zinc stearate dust for 7 years at a chemical factory, the amount of zinc retained in the lung was not significantly different from that found in lungs of persons not occupationally exposed to zinc stearate, and it was concluded that zinc stearate was not the cause of lung fibrosis in this worker (ACGIH (2017)).
(3) It was reported that, in a 209-day oral toxicity study using stearic acid (CAS RN: 57-11-4) as a test substance with rats dosed by feeding, severe pulmonary infection consisting of tracheobronchitis, lobular pneumonia, lipoid histiocytic response, and abscess formation developed at 3,000 ppm (150 mg/kg/day, in the range corresponding to "Not classified") (ACGIH (2017)).
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 Short term (Acute) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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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