Registration Dossier
Registration Dossier
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EC number: 200-836-8 | CAS number: 75-07-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- These data and information are based on the International Programme on Chemical Safety (IPCS) published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization (Environmental Health Criteria 167) and different published sources from the IUCLID dataset.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No method or guideline mentioned.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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:
- No details available.
Constituent 1
Method
- Target gene:
- Not applicable.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- S. typhimurium, other: TA104
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Not indicated.
- Test concentrations with justification for top dose:
- 40 µg/mL (Veghelyi et al. 1978)
0.88-441 µg/mL (Hemminki et al. 1980)
0.8 µg/mL (Igali & Gazso 1980)
1014 µg/plate (Marnett et al. 1985)
33-10'000 µg/plate (Mortelmans et al. 1986)
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Statistically significant mutagenic responses were induced in E.coli WP2uvrA in preincubation assays without metabolic activation at 37°C (Veghelyi et al., 1978) and 0°C (Igali & Gazso, 1980). In contrast, in another study on the same strain, results were negative (Hemminki et al., 1980).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Acetaldehyde was not mutagenic when tested adequately in standard preincubation assays with S. typhimurium. Statistically significant mutagenic responses were induced in E.coli WP2uvrA in preincubation assays without metabolic activation at 37°C (Veghelyi et al., 1978) and 0°C (Igali & Gazso, 1980). In contrast, in another study on the same strain, results were negative (Hemminki et al., 1980). Therefore, the substance will be not classified as mutagenic in the bacterial reverse mutation assay (Ames). - Executive summary:
These data and information are based on the International Programme on Chemical Safety (IPCS) published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization (Environmental Health Criteria 167) and different published sources from the IUCLID dataset. Acetaldehyde was not mutagenic when tested adequately in standard preincubation assays with S. typhimurium. Statistically significant mutagenic responses were induced in E.coli WP2uvrA in preincubation assays without metabolic activation at 37°C (Veghelyi et al., 1978) and 0°C (Igali & Gazso, 1980). In contrast, in another study on the same strain, results were negative (Hemminki et al., 1980). Therefore, the substance will be not classified as mutagenic in the bacterial reverse mutation assay (Ames).
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