NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	9003-04-7
Chemical Name	2-Propenoic acid, homopolymer, sodium salt
Substance ID	R03-A-002-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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 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.
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 the observation result that it is mixable with water (GESTIS (Accessed May 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) which 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	- -	-	-	Classification is not possible because 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) and (2), it was classified as "Not classified." [Reference Data, etc.] (1) LD50 for rats (males): > 4,000 mg/kg (CIR Expert Panel (2019)) (2) LD50 (cross-linked) for rats: > 2,000 mg/kg (DFG MAK (2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 (cross-linked) for rabbits: > 2,000 mg/kg (DFG MAK (2012)) (2) LD50 (cross-linked) for rats: > 2,000 mg/kg (DFG MAK (2012))
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. [Reference Data, etc.] (1) LD50 (cross-linked, exposure time unknown) for rats: 2.17 to 57.1 mg/L (DFG MAK (2012))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on the findings on this substance (cross-linked) in (1) to (5), it was classified as "Not classified." [Evidence Data] (1) It was reported that the test substance was applied occlusively for 48 hours to the skin of 25 to 30 patients with contact dermatitis or other skin diseases in patch tests, the exposed areas of skin were inspected 30 minutes and 24 hours after removal of the patches, and as a result, very slight redness of the skin was seen 30 minutes post applicationem in two patients, 24 hours post applicationem no skin reactions were observed (DFG MAK (2012)). (2) It was reported that the pure dry powder, 25% formulation (petrolatum) and 50% formulation (petrolatum) were applied to the skin of 12 persons under occlusive conditions for 24 hours on each of two consecutive days, and no skin reactions were observed (DFG MAK (2012)). (3) It was reported that 27 persons were exposed for 21 days continuously to a gel (physiological saline) containing the test substance, and no skin reactions were observed (DFG MAK (2012)). (4) It was reported that aliquots of 0.2 g per day of the granulated solid or a 10% suspension (physiological saline) were applied occlusively to the skin of 54 persons, in a cycle from Friday to Monday, for 21 days, and no significant signs of irritation were detected (DFG MAK (2012)). (5) All results in several dermal irritation tests with rabbits were negative (DFG MAK (2012)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Reference Data, etc.] (1) It was reported on this substance (cross-linked) that, in an eye irritation test using rabbits (n=6), mild signs of irritation developed about 24 hours post applicationem and then regressed completely within 3 days (DFG MAK (2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Reference Data, etc.] (1) In three maximization tests and two Buehler tests for this substance (cross-linked) with guinea pigs, no skin sensitization was observed (DFG MAK (2012)). (2) In several patch tests with this substance (cross-linked) on test persons, no skin sensitization was observed (DFG MAK (2012)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (7), it was classified as "Not classified." [Evidence Data] (1) In a mouse micronucleus test (OECD TG 474), negative results were reported (CIR Expert Panel (2019)). (2) In a micronucleus test for a non-cross-linked form of this substance by oral administration to mice (OECD TG 474), negative results were reported (CIR Expert Panel (2019)). (3) In a chromosomal aberration test for a cross-linked form of this substance by oral administration to rats (OECD TG 473), negative results were reported (DFG MAK (2012)). (4) In a chromosomal aberration test for a cross-linked form of this substance by intraperitoneal injection to rats (OECD TG 473), negative results were reported (DFG MAK (2012)). (5) In a bacterial reverse mutation test (OECD TG 471), negative results were reported (CIR Expert Panel (2019), Mutagenicity test results for chemical substances under the Industrial Safety and Health Law (OECD TG 471) (Accessed May 2021), EFSA (2013)). (6) In a mouse lymphoma cell assay, negative results were reported (CIR Expert Panel (2019)). (7) In an in vitro mammalian chromosomal aberration test (OECD TG 473), negative results were reported (CIR Expert Panel (2019)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) As for the classification results by domestic and international organizations, the DFG classified this substance in Category 4 (DFG MAK (2012): Classification in 1999). (2) In a carcinogenicity study with rats exposed by inhalation to fine particles of a cross-linked form of this substance for 104 weeks (6 hours/day, 5 days/week), an increase in the incidence of bronchiolar/alveolar adenocarcinomas (females), and an increase in the total incidence of bronchiolar/alveolar adenomas and adenocarcinomas were observed in the group exposed to the highest concentration of 0.8 mg/m3. It was considered that the increased lung tumors did not develop as the result of a genotoxic mechanism but rather were associated with massive inflammatory reactions (DFG MAK (2012)). [Reference Data, etc.] (3) The IARC classified polyacrylic acid in Group 3 (IARC Suppl. 7 (1984)), but this classification was based on the fact that there was no data that should be adopted as a rationale for the classification for this substance (IARC 19 (1979)).
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. No developmental toxicity effects were observed in (1), but there was no data about effects on fertility. [Evidence Data] (1) It was reported that, in a developmental toxicity study for this substance used as a test substance by oral administration to rats, there were no developmental effects (CIR Expert Panel (2019)). [Reference Data, etc.] (2) It was reported that, in a developmental toxicity study for a cross-linked form of this substance used as a test substance by inhalation exposure with rats (days 6-15 of gestation), there were no developmental effects (DFG MAK (2012)). (3) It was reported that, in a developmental toxicity study for a cross-linked form of this substance used as a test substance with rats dosed by feeding (days 6-15 of gestation), there were no developmental effects (DFG MAK (2012)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in the oral route and dermal route. However, classification was not possible due to lack of data since there was no information on toxicity in the inhalation route. Besides, the inhalation exposure test in (3) was not adopted as a rationale for the classification because the relationship between the exposure concentrations and the effects was uncertain. [Evidence Data] (1) It was reported that, in an acute oral toxicity test for a cross-linked form of this substance used as a test substance with rats and mice, no signs of toxicity were observed at 2,000 mg/kg (within the range for Category 2) (DFG MAK (2012)). (2) It was reported that, in an acute dermal toxicity test for a cross-linked form of this substance used as a test substance with rats and rabbits, no signs of toxicity were observed at 2,000 mg/kg (within the range for Category 2) (DFG MAK (2012)). [Reference Data, etc.] (3) It was reported that, in an acute inhalation exposure test for a cross-linked form of this substance used as a test substance with rats (exposure time unknown), piloerection, nasal discharge, respiratory noises, and higher relative lung weight were observed, and the LC50 values were in the range from 2.17 to 57.1 mg/L (from the range for Category 2 through the range corresponding to "Not classified") (DFG MAK (2012)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) to (3), since the target organs were considered to be the respiratory organs and effects were observed within the dose range for Category 1, it was classified in Category 1 (respiratory organs). [Evidence Data] (1) Respiratory diseases, such as fibrosis of lung tissues, occurred in multiple workers handling inhalant dust of cross-linked water-soluble acrylic acid polymers used in cosmetic and pharmaceutical products at a domestic chemical industrial products manufacturing plant, and workers' compensation claims were made. It was reported that, as a result of the study, it was concluded that the respiratory diseases could be caused by exposure to inhalant dust of acrylic acid polymers (Report on the "Study meeting on judgment on whether the pulmonary disorders that occurred at the manufacturing site of inhalant dust of cross-linked water-soluble acrylic acid polymer were occupational or non-occupational" (Ministry of Health, Labour and Welfare, 2019)). (2) It was reported that, in a 91-day repeated inhalation (dust) exposure test (5 days/week) for a cross-linked form of this substance used as a test substance with rats, an increase in intra-alveolar foam cell aggregates, interstitial cell proliferation, and thickening of the alveolar septa were observed at 0.0025 mg/L (converted guidance value: 0.0018 mg/L, within the range for Category 1) (DFG MAK (2012)). (3) It was reported that, in a 13-week inhalation (dust) exposure test (5 days/week) for a cross-linked form of this substance used as a test substance with rats, increased lung weight, alveolitis, increased alveolar macrophage count, and increased polymorphonuclear neutrophil count were observed at 0.001 mg/L (converted guidance value: 0.0007 mg/L, within the range for Category 1) and the formation of connective tissue (collagen deposition) in the lungs was observed at 0.01 mg/L (converted guidance value: 0.007 mg/L, within the range for Category 1) (DFG MAK (2012)). (4) It was reported that, in a 104-week inhalation (dust) exposure test (5 days/week) for a cross-linked form of this substance used as a test substance with rats, an increased in the incidence of non-neoplastic changes in the lungs (hyperplasia of the alveolar epithelium, bronchiolarization of the alveolar ducts, centroacinar alveolitis) was observed at 0.0002 mg/L (converted guidance value: 0.000143 mg/L, within the range for Category 1) and increased absolute and relative lung weight and increased weight of the tracheobronchial lymph nodes were observed after 26 and 52 weeks exposure, and increased lung weight was observed (females) after 104 weeks exposure at 0.0008 mg/L (0.0006 mg/L, within the range for Category 1) (DFG MAK (2012)). [Reference Data, etc.] (5) It was reported that, in a repeated dose 92-day oral toxicity study for a cross-linked form of this substance used as a test substance with rats dosed by feeding, increased kidney weight and changes in urinary electrolyte concentration were observed at or above 1,000 mg/kg/day (in the range corresponding to "Not classified") but there were no histopathological changes in the kidney (DFG MAK (2012)). (6) It was reported that, in a 13-week repeated dermal administration test for a cross-linked form of this substance used as a test substance by occlusive application to rats, no adverse effects were observed at 150 mg/kg/day (within the range for Category 2) (DFG MAK (2012)). (7) This substance is on the Assessment Stage I of the Risk Assessment (Primary) for Priority Assessment Chemical Substances in the Chemical Substances Control Law, and in the Assessment I which was conducted in 2020, the oral equivqalent NOAEL based on the inhalation experiment was set at 0.00003 [mg/kg/day].
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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment Long term (Chronic)	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.
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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