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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1971

Materials and methods

Principles of method if other than guideline:
Groups of 10 male Swiss white nice wexe treated as follows (in mg/kg/day except as noted): 60 doses of 0.4% acetic acid in water orally; TEL orally, 6.48, 32.00. The mice were mated with groups of 4 untreated females each week for consecutive weeks. Length of mating after treatment permitted testing of all meiotic and post meiotic germinal cells.
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals and environmental conditions:
The mice were mated with groups of 4 untreated females each week for consecutive weeks.

Administration / exposure

Route of administration:
oral: unspecified
Doses / concentrations
Remarks:
Doses / Concentrations:
TEL orally, 6.48mg/kg/day, 32.00mg/kg/day
Basis:
actual ingested
Dosage levels were selected on the basis of range¿finding experiments designed to determine maximally tolerated doses.
Control animals:
yes

Examinations

Tissues and cell types examined:
Testing of all meiotic and post¿meiotic germinal cells

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
Evidence of a toxic response to TEL was obtained during the Study. Reactions included hyperactivity, tremors, and increased irritability. Six mice died at the high dosage levels during the mating portion of the experiment.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The authors concluded that at maximally tolerated doses TEL did not promote a dominant lethal response in the mouse