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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-01-09 to 1979-02-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Detailed description of the method and the evaluation steps.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only a single test was performed with one plate per strain and concentration
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetaldehyde
EC Number:
200-836-8
EC Name:
Acetaldehyde
Cas Number:
75-07-0
Molecular formula:
C2H4O
IUPAC Name:
acetaldehyde
Details on test material:
- Substance type: clear colorless liquid
- Lot/batch No.: DMT-100

Method

Target gene:
histidin gene
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):
Periodically checked for relevant phenotypes
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
Periodically checked for relevant phenotypes
Metabolic activation:
with and without
Metabolic activation system:
S9 Homogenate from Aroclor 1254 induced male Sprague-Dawley rats accoridng to the procedure described by Ames et al. 1975
Test concentrations with justification for top dose:
0.005, 0.01, 0.1, 1, 5, 10 µL/plate
Vehicle / solvent:
not readable in the copy
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: For TA1535 and TA 100: Sodium azide; For TA1537: 9-Aminoacridine; For TA1535 and TA 98: 2-Nitrofluorene; For all strains with metabolic activation: 2-Anthramine
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period: no
- Exposure duration: 48 h, 37°C

NUMBER OF REPLICATIONS:
no replicates


DETERMINATION OF CYTOTOXICITY
yes
Evaluation criteria:
Strains TA 1535, TA 1537 and TA 1538: If the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered mutagenic.
Strains TA 98 and TA 100: If the solvent conrol value is within the normal range, a chemical that produces a positive response over three concentraions with the highest increase equal to twice the solvent control value for TA 100 and 2-3 times the solvent control value for strain TA 98 is considered to be mutagenic. For these strains, the dose response increase shold start at approximately the solvent control value.
Statistics:
no data

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:
cytotoxicity
Remarks:
at 10 µL per plate for strain TA 1535 slight toxicity was observed
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 10 µL per plate slight toxicity was observed
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Not mutagenic in the Bacteria Reverse Mutation assay under the reported conditions.
Executive summary:

Acetaldehyde was examined for mutagenic activity in the Slmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 with and without metabolic activation. The concentrations for the plate incoproration assay ranged from 0.05 µL/plate to 10 µL/plate. Slight toxicity was observed at 10 µL/plate for strain TA 1535 and TA 1538. Acetaldehyde did not show any mutagenic activity in any of the tests. The positive controls worked as expected.