GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 79-14-1
Chemical Name Hydroxyacetic acid
Substance ID 24A6057
Classification year (FY) FY2012
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) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 Classification not possible
-
-
- - No data available.
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 Classification not possible
-
-
- - No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 deg C) 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
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure.
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 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)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
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.
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)).
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.
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
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)).
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)).
6 Carcinogenicity Classification not possible
-
-
- - No data available.
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.
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.
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.
10 Aspiration hazard Classification not possible
-
-
- - No data available.

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) 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)).
11 Hazardous to the aquatic environment (Long-term) 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."
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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