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EC number: 288-752-8 | CAS number: 85895-78-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2014-01-17 to 2014-05-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-(+)-lactic acid
- EC Number:
- 201-196-2
- EC Name:
- L-(+)-lactic acid
- Cas Number:
- 79-33-4
- Molecular formula:
- C3H6O3
- IUPAC Name:
- (2S)-2-hydroxypropanoic acid
Constituent 1
- Specific details on test material used for the study:
- - Name: L(+)-lactic acid
- CAS No.: 79-33-4
- Appearance: clear colourless liquid
- Batch No.: 1208002033
- Purity: 90%
- Storage: at room temperature in the dark
- Expiry date: 2015-01-01
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: L(+)-lactic acid was dissolved in Milli-Q water (Millipore Corp., Bedford, MA., USA). Preparation of test solutions started with solutions of 50 mg/mL applying vortexing resulting in a clear colourless solution.
The lower test concentrations were prepared by subsequent dilutions in Milli-Q water. The stock solution was filter (0.22 μm)-sterilized. Test substance concentrations were used within 2 hours after preparation.
Method
- Target gene:
- Salmonella typhimurium: Histidine
E. coli: Tryptophane
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Trinova Biochem GmbH, Germany (Master culture from Dr. Bruce N. Ames) - Additional strain / cell type characteristics:
- other: each strain contained the following additional mutations: rfa, gal, chl, bio, uvrB
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELL SOURCES:
- Source of cells: Master culture from The National Collections of Industrial and Marine Bacteria, Aberdeen, UK - Additional strain / cell type characteristics:
- other: The Escherichia coli WP2uvrA strain detects base-pair substitutions
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Selection of an adequate range of doses was based on a dose range finding test with the strains TA100 and WP2uvrA.
Strains TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
Strains TA1535, TA1537 and TA98: 100, 333, 1000, 3330 and 5000 µg/plate
The highest concentration of L(+)-lactic acid used in the subsequent mutation assay was 5000 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Milli-Q water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9; WP2uvrA; 15 μg/plate; dissolved in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9; TA100; 650 μg/plate; dissolved in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9; TA98; 10 μg/plate; dissolved in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Millli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- without S9; TA1537; 2.5 μg/plate; dissolved in DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9; TA1535; 5 μg/plate; dissolved in saline
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9; 1 µg/plate (TA98: 5 and 10% S9, TA100: 5% S9), 2 µg/plate (TA100: 10% S9), 2.5 µg/plate (TA1535: 5 and 10% S9; TA1537: 5% S9); dissolved in DMSO
- Details on test system and experimental conditions:
- Dose Range Finding Test:
Selection of an adequate range of doses was based on a dose range finding test with the strains TA100 and WP2uvrA, both with and without 5% (v/v) S9-mix. Eight concentrations, 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate were tested in triplicate. The highest concentartion of lactic aqcid used in the subsequent mutation assay was 5000 µg/plate.
Mutation Assay:
At least five different doses (increasing with approximately half-log steps) of the test substance were tested in triplcate in each strain. In the first experiment the test item was tested both in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. In an independent repeat of the assay with additional parameters, the test substance was tested both on the absence and presence of 10% (v/v) S9-mix in all tester strains. The negative control (vehicle) and relevant postive controls were concurrently tested in each strain in the presence and absence of S9-mix.
Top agar in top agar tubes was melted by heating to 45 °C. The following solutions were successively added to 3 mL molten top agar: 0.1 mL of a fresh bacterial culture (10^9 cells/mL) of one of the tester strains, 0.1 mL of a diltuin of the test substance in Milli-Q-water and either 0.5 mL S9-mix or 0.5 mL 0.1 M phosphate buffer. The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were inverted and incubated in the dark at 37.0 °C +/- 1.0 °C for 48 +/- 4 hours. After this period revertant colonies were counted.
NUMBER OF REPLICATIONS: 3
Colony counting:
The revertant colonies were counted manually and evidenve of the test article precipitation on the plates was recorded.
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn was evaluated. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or
WP2uvrA is not greater than three (3) times the concurrent vehicle control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is greater than two times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is greater than three times the concurrent vehicle control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- not applicaple
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA1535, TA1537, TA98, TA100, E.coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No
RANGE-FINDING/SCREENING STUDIES: Dose range finding test performed with TA100 and WP2uvrA. Doses tested: 0, 3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate. Based on the results, the following doses were selected for the main experiment with TA1535, TA1537 and TA98 in the presence and absence of S9-mix: 100, 333, 1000, 330 and 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: The negative control values were within the laboratory historical control data ranges, except for TA100 in the absence of S9-mix, second experiment. Evaluation: The mean plate count (146) was just outside the limit of the range (144) and clear negative results are observed in all experiments. Therefore, this deviation in the mean plate count of the solvent control had no effect on the results of the study. The strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly, except the response for TA1535 in the absence of S9-mix, first experiment. Evaluation: The value (257) was just below the limit of the range (262). The purpose of the positive control is as a reference for the test system, where a positive response is required to check if the test system functions correctly. Since the value was more than 3 times greater than the concurrent solvent control values, this deviation in the mean plate count of the positive control had no effect on the results of the study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
MUTAGENICITY:
Experiment 1: No increase in the number of revertants was observed upon treatment with the test item under all conditions tested.
Experiment 2: Based on the results from the first experiment, the test item was tested up to 5000 µg/plate. No increase in the number of revertants was observed.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, L(+)-lactic acid is not genotoxic in the bacterial reverse gene mutation assay (OECD 471) in the presence and absence of mammalian metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria conducting according to OECD guideline 471, Salomella typhimurium strains TA1535, TA1537, TA98, TA100 and E. coli strain WP2uvrA were exposed to L(+)-lactic acid (90% purity) at concentrations of 0, 100, 333, 1000, 3330 and 5000 µg/plate in the presence and absence of mammalian metabolic activation.
L(+)-lactic acid was tested up to the limit concentration of 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. Based on the results, the test item can be considered to be non-mutagenic.
This study is classified as acceptable and satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation assay).
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