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 |
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 |
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. |
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. |
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. |
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