NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	9005-67-8
Chemical Name	Polyoxyethylenesorbitan fatty acid ester
Substance ID	25A0020
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point is > 150 deg C (closed-cup) (NITE Chemical Risk Information Platform (NITE-CHRIP) (Access on August 2013)) and is above 93 deg C.
7	Flammable solid	Not applicable	- -	-	-	Liquid (GHS definition)
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	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data 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	- -	-	-	It was classified as "Not classified" on the basis that in 13-week, 1-year, or 2-year diet administration tests with experimental animals (rats, mice), no adverse effects were observed, or only effects on the gastrointestinal tract (diarrhea, dilatation of the cecum) were found at the extremely high doses (500-5,000 mg/kg/day) (JECFA (1973), Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)).
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	It is described in Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007) that as a result of the application of undiluted or aqueous solutions of this substance to the skin of rabbits and mice, slight irritation to necrosis of the skin was observed. However, it is not a test according to the guideline, and it is described that after application of a 25% aqueous solution of this substance to the scalp of humans, slight erythema was found, but the details are unknown. Therefore, it was classified as "Classification not possible" due to lack of data.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data.
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. It is reported in Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007) that after application of the cream in which this substance was used as a base or this substance itself to the forehead skin of humans, urticaria developed at the site after 20 minutes while no effects were seen in the skin of back and arms. However, due to unknown details on positive rates, etc., it was classified as "Classification not possible."
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no in vivo data. As for in vitro, it was negative in a bacterial reverse mutation test and a chromosomal aberration test with cultured mammalian cells (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)).
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. No carcinogenicity was observed in any of 2-year diet administration carcinogenicity tests with Wistar and Osborne-Mendel male and female rats, a 13-month diet administration test with male hamsters, a 4-month diet administration test with male and female mice, a 1-year diet administration test with beagle dogs. Furthermore, in a test by dermal application (twice or six times per week) to mice, benign skin tumors were found in 40-50% of animals after 30 weeks or more, but most of the tumors regressed after continued dosing (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)). However, these tests did not follow the current test guidelines for carcinogenicity, and test conditions such as the number of animals and dosing periods are not sufficient to evaluate carcinogenicity. Besides, the US Food and Drug Administration (FDA) concluded that there was no risk of carcinogenicity for polysorbate (including this substance, polysorbate 60) in humans. From the above, it was classified as "Classification not possible."
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. There are no data from a reproductive toxicity test. As for a developmental toxicity test, in tests with rats and mice in the oral route (gavage or feeding), increased mortality of embryos/fetuses of rats at 7,693 mg/kg/day and effects on weight gain in mouse neonates at 5,200 mg/kg/day were observed (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)). However, these were thought to be effects at the doses that far exceeded doses of usual toxicity tests.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, as for polysorbates in the oral route, it is reported that there were no clear adverse effects in humans (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)). However, because of no toxicity information on the other routes, the classification is not possible due to lack of data as a whole.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	Toxicity effects were not seen after ingestion in humans (Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)). Also in 13-week, 1-year or 2-year diet administration tests (500-5,000 mg/kg/day) with experimental animals (rats, mice), no adverse effects were found, or only effects on the gastrointestinal tract (diarrhea, dilatation of the cecum) were observed at the extremely high doses (JECFA (1973), Risk Assessment Report (Food Additives) (Food Safety Commission of Japan, 2007)). Therefore, it corresponds to "Not classified" in the oral route. However, because of no toxicity information on the other routes, the classification is not possible due to lack of data as a whole.
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	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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