Registration Dossier
Registration Dossier
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EC number: 201-075-4 | CAS number: 78-00-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- No information
- Author:
- Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., Zeiger, E.
- Year:
- 1 986
- Bibliographic source:
- Environ. Mutagen. Vol 8, pp 1-119
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Principles of method if other than guideline:
- TEL was investigated in the Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537
- GLP compliance:
- no
- Remarks:
- test completed before GLP implementation
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetraethyllead
- EC Number:
- 201-075-4
- EC Name:
- Tetraethyllead
- Cas Number:
- 78-00-2
- Molecular formula:
- C8H20Pb
- IUPAC Name:
- tetraethylplumbane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat/Hamster liver
- Test concentrations with justification for top dose:
- 1-1000 µg TEL/plate dissolved in DMSO (0/10/33/100/333/1000 µg/Plate)
- Details on test system and experimental conditions:
- Ames test
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- not specified
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
TEL at dose levels of 1-1000 µg/plate in DMSO, proved to be non mutagenic in an Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537 - Executive summary:
TEL at dose levels of 1-1000 µg/plate in DMSO, proved to be non mutagenic in an Ames test on Salmonella typhimurium TA 98, TA 100 and TA 1537
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