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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Two Ames test studies using TEL using treat rates of 1-1000 µg/plate in DMSO and 1-100 µg/plate in ethanol proved TEL to be non mutagenic on Salmonella typhimurium TA 98, TA 100 and TA 1537. A similar study on the analogous substance TML would support this finding.
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to
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
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
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:
not specified
Conclusions:
Interpretation of results (migrated information):
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

No evidence of mutagenic activity was seen in two good quality Ames tests, using TEL concentrations of 1-1000 µg/plate in DMSO and 1-100 µg/plate in ethanol in Salmonella typhimurium strains TA 98, TA 100 and TA 1537, with and without mammalian metabolic activation (S9) (Mortelmans et al. 1986). A similar study on the analogous substance tetramethyl lead (TML) was also negative (Ames, 1975).

Investigations on Drosophilia melanogaster showed TriEL (a degradation product of TEL) to cause disturbances in nuclear division.  (Ramel et al 1979)

Investigations on mice showed at maximally tolerated doses TEL did not promote a dominant lethal response (Kennedy et al 1971)

 

Justification for classification or non-classification

TEL was negative in two good-quality Ames tests at up to 1000 µg/plate, with and without S9. Investigations on mice showed at maximally tolerated doses TEL did not promote a dominant lethal response Kennedy et al 1971) TEL is not classified as mutagenic in Annex I of the EU DSD or according to CLP regulations.