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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
- Life Cycle description
- Uses advised against
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Publication, results are based on the read-across partner 2-Methyl-1-propanol (isobutanol).
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the genotoxic potential of some microbial volatile organic compounds (MVOC) with the comet assay, the micronucleus assay and the HPRT gene mutation assay
- Author:
- Kreja L
- Year:
- 2 002
- Bibliographic source:
- Mutation Research 513 (2002): 143-150
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- no positive control in the experiment with metabolic activation reported
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2-methylpropan-1-ol
- EC Number:
- 201-148-0
- EC Name:
- 2-methylpropan-1-ol
- Cas Number:
- 78-83-1
- Molecular formula:
- C4H10O
- IUPAC Name:
- 2-methylpropan-1-ol
- Reference substance name:
- isobutanol
- IUPAC Name:
- isobutanol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): 2-Methyl-1-propanol
Constituent 1
Constituent 2
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
without metabolic activation: MEM Eagle medium with 10% fetal calf serum, 2mM L-glutamine, 100 IU/mL penicillin and streptomycin
with metabolic activation: above mentioned medium plus 3% S9-mix - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- only the highest non-toxic concentration tested is reported: 107 mM
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- final concentration: 0.5 mM
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in medium
DURATION
- Preincubation period: 24h
- Exposure duration: 2h
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 7 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14 days
SELECTION AGENT (mutation assays): 6-thioguanine (10 µg/mL)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The test compound was classified as a mutagen when it was able to enhance in a concentration-depended manner the spontaneous HPRT frequency by a factor of three or more.
- Statistics:
- N.A.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutant frequency for HPRT gene in V79 cells
Substance | Highest non toxic concentration tested (mM) | Mutant frequency (x 106) | |||
without S9 | with S9 | ||||
Negative Control | 0 | 0 - 2.8 | 0 - 3.1 | ||
MMS (Positive control) | 0.5 | 92 | - | ||
2-Methyl-1-propanol | 107 | 0 | 1.3 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
In conclusion, in the described in vitro cell gene mutagenicity test under the experimental conditions reported, the test item 2-Methyl-1-propanol is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster. - Executive summary:
In a mammalian cell HPRT gene mutation assay similar to OECD guideline 476, V79 cells cultured in vitro were exposed to 2-Methyl-1-propanol in medium. The highest non toxic concentration reported and tested was 107 mM in the presence and absence of mammalian metabolic activation. No increase in mutant frequency was observed after treatment with 2-Methyl-1-propanol in comparison to the untreated control. The positive control did induce the appropriate response. 2-Methyl-1-propanol (isobutanol) is used as read-across partner to isobutyl-R-lactate.
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