GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 79-33-4 |
| Chemical Name | L-Lactic acid |
| Substance ID | H28-B-061, C-127B |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2012 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 |
- |
- | - | 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 is 110 deg C (closed cup) (ICSC(J) (1997)). |
| 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 in the molecule |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 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. |
| 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." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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. |
| 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. |
| 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. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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." |
| 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)). |
| 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)). |
| 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)). |
| 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)). |
| 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)). |
| 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). |
| 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 |
- |
- | - | 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." |
| 11 | Hazardous to the aquatic environment (Long-term) | 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." |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |