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GHS Classification Result

GENERAL INFORMATION

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

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)
Model SDS by MHLW (External link)
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	- -	-	-	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.

HEALTH HAZARDS

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.

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)	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.

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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