Acetaldehyde

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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 / strain

Species / strain 1

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 2

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 results

Test results 1

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

Test results 2

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.