NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	79-33-4
Chemical Name	L-Lactic acid
Substance ID	m-nite-79-33-4_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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	A flash point is 110 deg C (closed cup) (ICSC(J) (1997)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	It is written that it is an acid of moderate strength (ICSC(J) (1997)), but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)	Not classified	- -	-	-	Based on a report of the LD50 values of 3,543 - 4,936 mg/kg for rats (SIAP (2011)), this substance was classified as "Not classified." 　Note that data used in the previous classification from JECFA 344 (1974) was not adopted because the data was for an isomeric mixture (DL-) of this substance.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of > 2,000 mg/kg for rabbits (SIAP (2011)), this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on a report of an LC50 value (4 hours) of > 7.9 mg/L for rats (SIAP (2011)), this substance was classified as "Not classified." 　Note that because the LC50 was higher than the saturated vapor pressure concentration (0.40 mg/L), the reference value of mist in the unit of mg/L was adopted.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	Since a dermal irritation test (OECD TG 404) using rabbits with this substance indicated severe irritation, and it was corrosive (SIAP (2011)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In an eye irritation test on lactic acid which is not specified as this substance using rabbits, corrosivity, persistent scarring, loss of the epithelial layer of the cornea, and adhesion of the cornea and iris were observed (HSDB (Access on September 2016)). Moreover, since this substance is classified in Category 1 for Skin Corrosion/Irritation, it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	It is reported that a skin sensitization test (Buehler method) of this substance in guinea pigs was negative (SIAP (2011)), and a skin sensitization test (maximization method) in guinea pigs on lactic acid which is not specified as this substance was negative (HSDB (Access on September 2016)). However, as the details of the results are unknown, this substance was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There is no in vivo data. 　As for in vitro, it is reported that a bacterial reverse mutation test was negative (SIAP (2011), NTP DB (Access on September 2016)), a cultured mammalian cell chromosome aberration test was positive (due to low pH) and negative (when the medium was neutralized) (SIAP (2011)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, there is a report that in a 2-year study in rats administered with calcium lactate in their drinking water, no evidence of carcinogenicity was observed (SIAP (2011)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, there is a report that in a developmental toxicity study in which pregnant mice were given by gavage during the organogenesis period (gestational days 6-15) at 570 mg/kg/day, no abnormality was found in either dams or offspring (SIAP (2011)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, there is a report that in a single oral dose of this substance to rats, symptoms including lethargy, ataxia, prostration, irregular breathing were observed, and the LD50 value was 3,543 - 4,936 mg/kg (SIAP (2011)). Moreover, there is a report that in a single inhalation exposure to this substance for 4 hours to rats, rapid breathing, lacrimation, hunched posture, additionally, lethargy (only in females) were observed, and the LC50 value was > 7.9 mg/L (SIAP (2011)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	As for experimental animals, in 13-week repeated dose toxicity studies using rats administered via diet or drinking water, slight suppression in body weight gain and changes in some hematological and biochemical parameters were observed. However, it is written that the NOAEL was 500 mg/kg/day, the highest dose tested (SIAP (2011)). Moreover, it is written that in a 2-year repeated dose toxicity study using rats administered via drinking water, only a reduction in body weight gain was observed at the highest dose level of 5% (SIAP (2011), HSDB (Access on September 2016), JECFA FAS 48 (2002)). In 14-week repeated dose toxicity studies using hamsters administered by diet or drinking water, no effects were observed in terms of general symptoms, body weight, etc. (HSDB (Access on September 2016)). However, details including the accurate dose etc. are unknown. Additionally, there are reports that no adverse effects were observed when dogs were orally administered 600 - 1,600 mg/kg for 2.5 months (JECFA 344 (1974)), and that, as a result of a test where 886 mg/kg were applied dermally to rats for 13 weeks, brain and kidney weights increased; however, no lesions were observed on gross or microscopic examination (HSDB (Access on September 2016)). 　Therefore, this substance was classified as "Not classified." 　Besides, humans have consumed fruit, sour milk and other fermented products containing this substance for centuries, without any adverse effects. On the other hand, it is known that newborn infants can not tolerate lactic acid. In such cases, rapid loss of weight, diarrhoea, reduction of plasma bicarbonate and increased excretion of organic acids in the urine are reported (JECFA 344 (1974)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, from numerical data (viscosity: 6.69 - 28.50 MPa*s (64.89% - 85.32%, 25 degC), density (specific gravity): 1.2) described in HSDB (Access on September 2016), kinematic viscosity is calculated as 5.58 - 23.8 mm2/sec (25 degC).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Not classified	- -	-	-	From 48-hour EC50 = 240 mg/L for crustacea (Daphnia magna) and 96-hour LC50 = 130 mg/L for fish (Lepomis macrochirus) (both SIAP (Conclusions Agreed in CDG, 2011)), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. Due to being not poorly water-soluble (water solubility = 876 g/L, SIAP (Conclusions Agreed in CDG, 2011)), and "Not classified" for acute toxicity, it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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