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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo insect germ cell study: gene mutation
Remarks:
sex-linked recessive lethal (SLRL) assay in D. melanogaster.
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically well conducted study, part of the NTP testing program

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Chemical mutagenisis testing in Drosophila. V. Results of 53 coded compounds for the national testing program
Author:
Woodruff R.C., Mason J.M., Valencia R. and Zimmering S.
Year:
1985
Bibliographic source:
Environ. Mutagen. 7, 677-702
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Sex-linked recessive lethal assay
Appropriate statistical evaluations. Cluster analysis by Poisson distribution; normal test of lethal frequencies after clusters removed Glass fiber discs, saturated with the test compound carried a 5% sucrose solution were used to expose males for 3 days in glass shell vials. Males were mated immediately after treatment with 3 new females for each of 3 broods.
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: Not specified
Purity: 72-91%

Test animals

Species:
Drosophila melanogaster
Strain:
other: Canton-S wild-type
Sex:
male
Details on test animals and environmental conditions:
None stated

Administration / exposure

Route of administration:
oral: feed
Vehicle:
5% sucrose solution
Details on exposure:
None stated
Duration of treatment / exposure:
72 hours
Frequency of treatment:
exposure was assumed to be constant, via food source.
Post exposure period:
Immediately
Doses / concentrations
Remarks:
Doses / Concentrations:
1150 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
Given as "10-20 animals per vial"
Control animals:
not specified
Positive control(s):
None stated

Examinations

Tissues and cell types examined:
None stated
Details of tissue and slide preparation:
None stated
Evaluation criteria:
Criteria for positive results: if no wild-type males were identified among 20 or more Basc nales or Bascl +/- females, then it was considered a lethal mutation. If a few F2 or F3 wild-type males survived at <5% of Basc males or Bascl +/- females then it was considered a lethal mutation.
Statistics:
None stated

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Additional information on results:
No information provided

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The test substance has no induction of SLRL in Drosophila melanogaster.
Executive summary:

Sex-linked recessive lethal assay: Appropriate statistical evaluations. Cluster analysis by Poisson distribution; normal test of lethal frequencies after clusters removed Glass fiber discs, saturated with the test compound carried a 5% sucrose solution were used to expose males for 3 days in glass shell vials. Males were mated immediately after treatment with 3 new females for each of 3 broods.

The test substance has no induction of SLRL in Drosophila melanogaster.