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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Primary mutagenicity screening of food additives currently used in Japan.
Author:
Ishidate M. Jr., Sofuni T., Yoshikawa K., Hayashi M., Nohmi T., Sawada M., Matsuoka A.
Year:
1984
Bibliographic source:
Food Chem. Toxic. 22: 623-636

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Lactic acid
EC Number:
200-018-0
EC Name:
Lactic acid
Cas Number:
50-21-5
Molecular formula:
C3H6O3
IUPAC Name:
2-hydroxypropanoic acid

Method

Target gene:
Histidine locus
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver homogenate S9
Test concentrations with justification for top dose:
10 mg/plate, resp 1.0 mg/mL (Ames test)
Vehicle / solvent:
water: phosphate buffer (Ames test)
Controls
Untreated negative controls:
yes

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium, other: TA92, TA94, TA2637
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions reported, lactic acid did not cause gene mutations. Therefore, the test item is considered to be non-mutagenic in the bacterial reverse gene mutation assay.
Executive summary:

In a reverse gene mutation assay in bacteria, strains TA92, TA1535, TA100, TA1537, TA94, TA98 and TA2637 of S. typhimurium were exposed to 242 food additives including lactic acid. S. typhimurium strains were exposed to lactic acid at concentrations of 10 mg/plate (equivalent to 1.0 mg/mL) in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies and cytotoxicity with and without metabolic activation. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse gene mutation assay.