NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	79-14-1
Chemical Name	Hydroxyacetic acid
Substance ID	m-nite-79-14-1_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 associated with explosive properties present in the molecule.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on an LD50 value of 1,357 mg/kg for rats (GLP-compliant) (NICNAS (2000)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	There are LC50 values of 2.52 mg/L/4 hours (males) and > 3.64 mg/L/4 hours (females) for rats (GLP-compliant) (NICNAS (2000)), one corresponds to Category 4, and the other corresponds to "Classification not possible" because the category cannot be determined with this. From a safety point of view, the category with higher hazard was adopted, and it was classified in Category 4. Besides, because it is described that the above test was conducted on aerosols of a 70% aqueous solution of this substance, a reference value of mist was applied.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 1B	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In skin irritation tests with rabbits on this substance of purity 99% (cosmetic grade) and a 70% aqueous solution of this substance (technical grade) (tests according to OECD TG404 or similar protocols, GLP-compliant), visible necrosis through the epidermis and into the dermis was observed after a 1-hour application, and it was judged as corrosive (NICNAS (2000)). Therefore, it was classified in Category 1B. Besides, the pH of a 70% aqueous solution of this substance was < 0.5 (NICNAS (2000)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In an eye irritation test in which 0.1 mL of a 64% aqueous solution of this substance (cosmetic grade) was applied to rabbits, irreversible damage including blindness was observed, and in a test on a 57% aqueous solution (technical grade) (pH 1.8) (OECD TG405, GLP-compliant), irreversible opacity and vascularization of the cornea and reversible conjunctival erythema and edema were found (both NICNAS (2000)). Therefore, it was classified in Category 1.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Not classified	- -	-	-	It was classified as "Not classified" because it is reported that the positive rate was 0% (0/20) in a Modified Buehler test (GLP-compliant) with 20 guinea pigs on a 70% aqueous solution of this substance (technical grade) (USEPA/HPV (2001)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow cells after gavage administration of a 70% aqueous solution of this substance (technical grade) to mice (in vivo somatic cell mutagenicity test) (NICNAS (2000)). Besides, as for in vitro tests, negative results were obtained in an Ames test and a chromosomal aberration test with CHO cells (NICNAS (2000), NTP DB (1997)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a test by gavage administration to female rats on gestational days 7-21 (doses: 75, 150, 300, 600 mg/kg/day) (GLP), at the dose where general toxicity such as reduced weight gain and decreased food consumption was observed in maternal animals, decreased body weights and an increased incidence of malformations (mainly anomalies in the sternebrae and vertebra, others: heart septal defects, microphthalmia, absent kidney, cleft palate, gastroschisis, omphalocele, etc.) were significantly found in fetuses compared to the control group (NICNAS (2000)). And as a result of 90-day oral exposure (doses: 150, 300, 600 mg/kg/day) to rats, followed by mating and continuous administration during mating, gestation, and lactation period, at the doses where parent animals showed general toxicity, there were no adverse effects related to mating, implantation, and gestation, but a dose-dependent decrease in litter size was observed (NICNAS (2000)). It was classified in Category 2 from the above information.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	In a test with rats by 4-hour inhalation exposure to aerosols of a 70% aqueous solution of this substance (technical grade) (doses: 0.6, 2.1, 3.8, 5.2 mg/L), clinical signs of gasping, hunched posture, and nasal and ocular discharge at all levels, and lethargy at 2.1 and 3.8 mg/L were observed. Changes attributable to irritation in the nasal cavity, larynx, and lung were seen at the microscopic examination, and nasal lesions (degeneration/regeneration of respiratory and olfactory epithelium), and laryngeal ulceration in all treated groups, and subacute/chronic inflammation in the lung at or above 2.1 mg/L were observed (USEPA/HPV (2001)). It was classified in Category 1 (respiratory system) because this substance is corrosive to the skin, and the above findings were seen at doses corresponding to the guidance values for Category 1.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, thymus)	Warning	H373	P260 P314 P501	In a test with rats by 14-day (6 hours/day) inhalation exposure to aerosols of a 70% aqueous solution of this substance (technical grade) (doses: 0.16, 0.51, 1.4 mg/L/day, converted guidance value: 0.02, 0.064, 0.175 mg/L/day), increases in serum aspartate aminotransferase (AST) in the 0.51 mg/L/day group, and AST and alanine aminotransferase (ALT) in the 1.4 mg/L/day group were observed, and the microscopic examination revealed mild diffuse hepatocellular degeneration and atrophy and degeneration of the thymus (USEPA/HPV (2001)). Because the above findings were found within the guidance value range for Category 2, it was classified in Category 2 (liver, thymus). And it is described that the NOAEL was 150 mg/kg/day in a 90-day repeated toxicity test by gavage administration of a 70% aqueous solution of this substance (technical grade) to rats (doses: 150, 300, 600 mg/kg/day) (USEPA/HPV (2001)), and because it was above the guidance values for Category 2, it corresponds to "Not classified" in oral administration.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 44 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1998)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified in Category 3 in acute toxicity. However, it is rapidly degradable (readily biodegradable, BOD: 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and low bioaccumulation is estimated (LogKow = -1.11 (PHYSPROP Database, 2009)). Therefore, it was classified as "Not classified."	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）

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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