Item | Information |
---|---|
CAS RN | 50-21-5,598-82-3,79-33-4,10326-41-7 |
Chemical Name | Lactic acid (DL-, L-, D-) |
Substance ID | 24A6053 |
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) | |
Model SDS by MHLW (External link) | |
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 |
- |
- | - | 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 of 110 deg C [closed-cup] (ICSC (1997)) is above 93 deg C. |
7 | Flammable solids | 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. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
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" in the Classification JIS (corresponding to Category 5 in UN GHS classification) based on an LD50 value of 3,730 mg/kg for rats (JECFA 344 (1974)). Besides, this substance is an isomer mixture of L-lactic acid (CAS 79-33-4) and D-lactic acid (CAS 10326-41-7), and information on the L-isomer was also described in some hazard class. |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. Besides, for the L-isomer, there is a report on an LD50 value of > 2,000 mg/kg for rabbits (SIDS (2008)), corresponding to "Not classified." |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. Besides, for the L-isomer, there is a report on an LD50 value by 4-hour exposure (aerosol) of > 7.94 mg/L for rats (SIDS (2008)), corresponding to "Not classified." |
2 | Skin corrosion/irritation | Category 1 |
Danger |
H314 |
P301+P330+P331
P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501 |
It was classified in Category 1 because it is described that the pH of this substance was about 1.2 (USEPA/HPV (2002), corresponding to List 1). Besides, it is reported that it was not irritating in a test in which sodium hydroxide was added to this substance (80%) as a buffer and was applied to rabbits (OECD TG 402, GLP) (USEPA/HPV (2002)), and it was corrosive in a test in which the L-isomer of this substance (88%) was applied to rabbits (OECD TG 402, GLP) (USEPA/HPV (2002)). |
3 | Serious eye damage/eye irritation | Category 1 |
Danger |
H318 |
P305+P351+P338
P280 P310 |
It was classified in Category 1 because it is described that the pH of this substance was about 1.2 (USEPA/HPV (2002)), and in a test in which 750 microg of this substance was applied to the rabbit eye, the severity of damage was 8 on a scale from 1 to 10 (10 being the most severe) and severe (RTECS (2010): the original article, American Journal of Ophthalmology: 29, 1363, 1946). Besides, it was also classified as a corrosive substance in skin corrosion/irritation. |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. |
4 | Skin sensitization | Not classified |
- |
- | - | It was classified as "Not classified" because it was concluded that it was not sensitizing in a maximization test with guinea pigs (USEPA/HPV (2002), HSDB (2006)). Besides, also for the L-isomer of this substance, it is reported that it was not sensitizing in a Buehler test with guinea pigs (EPA OPP 81-6, GLP) (USEPA/HPV (2002)). |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it is reported that it was negative in an Ames test (NTP DB ID: A10575 (1997)), positive in a chromosomal aberration test (pseudo-positive due to low pH) (Mutat Res., 240, 195-202, (1990)), and negative in a chromosomal aberration test with CHO cells (SIDS (2008)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | No data available. Besides, it is reported for calcium lactate that there was no evidence of carcinogenicity in a 2-year drinking water administration test with rats (SIDS (2008)). |
7 | Reproductive toxicity | Classification not possible |
- |
- | - | Data are lacking. Besides, it is described that there were no effects on maternal animals or the development of offspring in a test by oral administration of 570 mg/kg/day to pregnant mice during the organogenesis period (SIDS (2008)), but the details are unknown, and effects on sexual function and fertility are unknown. |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | It is reported that after oral administration to rats, one out of five animals at 650 mg/kg and two out of five animals at 1,300 mg/kg died within 24 hours, and after re-administration of the same amounts to surviving animals after eight days, two in the 1,300 mg/kg group showed dyspnea, snivel, vomiting, and abdominal inflation and died (HSDB (2006)). However, because the further details are unknown, it was classified as "Classification not possible." Besides, in an acute oral toxicity test on the L-isomer (LD50 value: 3,543-4,936 mg/kg), symptoms such as lethargy, ataxia, prostration, and irregular breathing were observed (USEPA/HPV (2002)). |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | It is reported that no effects on general symptoms, body weight, etc. were observed in a 90-day oral administration test with rats or a test by 14-week administration by feeding or drinking water to hamsters (USEPA/HPV (2002)), but the details such as accurate doses are unknown, and it is reported that there were no adverse effects after 2.5-month oral administration of 600-1,600 mg/kg to dogs (JECFA 344 (1974)). And it is reported that weights of the brain and kidney increased after 13-week dermal administration of 886 mg/kg to rats, but no lesions were found at visual and microscopic examination (USEPA/HPV (2002)). However, because the test details are unknown in either test, it was classified as "Classification not possible" due to lack of data. |
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) | Not classified |
- |
- | - | It was classified as "Not classified" from 96-hour LC50 = 130 mg/L for fish (Lepomis macrochirus) (SIDS, 2011). |
11 | Hazardous to the aquatic environment (Long-term) | Not classified |
- |
- | - | Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (ready biodegradable, BOD: 76% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and it was classified as "Not classified" in acute toxicity. |
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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