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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Principles of method if other than guideline:
CD-1 mice were treated with TDCP at concentrations of 0.05 to 0.5 ml/kg/day (corresponding to 75.65, 257.2 and 756.5 mg/kg) for 5 days after which time the urine was tested for the ability to induce an increase in revertants in TA strains 1535, TA 1537, TA 98 and TA 100, both deconjugated and non-deconjugated urine samples were tested.
GLP compliance:
no
Type of assay:
other: This non-standard test involved treatment of mice with TDCP and an Ames test with the animals urine.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: not stated

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc?, Portage, Michigan.
- Age at study initiation: > 8 weeks
- Housing: Shoe box cages on ab-sorb-dri bedding
- Diet (e.g. ad libitum): Purina Lab Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
Animals were treated daily for 5 days.
Frequency of treatment:
Daily.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
75.65 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
257.2 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
756.5 mg/kg
Basis:
no data
No. of animals per sex per dose:
Not specified.
Positive control(s):
No data.

Examinations

Tissues and cell types examined:
The number of revertant colonies of Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 were calculated in response to pre-treated mouse urine.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
A single plate was used for each data point and no positive control data were included.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative