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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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Refer chapter 13 for detailed read across justification.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Test material was obtained from Fisher Scientific Co., Fair Lawn, NJ (U.S.A.);

Test animals

Species:
Drosophila melanogaster
Strain:
other: The Berlin K (wild-type) and Basc strains were used.
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
2 % Tween 80
Details on exposure:
In Drosophila one dose close to the LD50 (0.25 mM) was applied by the adult feeding method in 5 % saccharose.
Doses / concentrationsopen allclose all
Dose / conc.:
0.25 other: mM
Dose / conc.:
42.02 other: mg
Remarks:
Dose was not specified in terms of 'per kg'

Results and discussion

Test results
Key result
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.
Executive summary:

Sodium hexafluorosilicate was evaluated for the potential to induce mutations in a Drosophila melanogaster sex linked recessive lethal assay. Drosophila melanogaster strains: Berlin K (wild-type) and Basc, were used. In the tested Drosophila, one dose close to the LD50 (0.25 mM or 42.02 mg) was applied by the adult feeding method in 5 % saccharose. About 1200 X-chromosomes (brood 1: 1226, brood 2: 1212 and brood 3: 1236) were tested per experiment in each of 3 successive broods (3-3-4 days). In repeat experiments, sometimes only single broods were tested. F: progeny cultures with 2 or fewer wild-type males were routinely retested in the F3 generation to confirm X-linked recessive lethal mutations (RLs). Mosaics were not counted. "Clusters" of 2 were included because their occurrence was compatible with statistical expectation of independent origin. Of the tested chromosomes, only a small portion (brood 1: 3 out of 1226, brood 2: 1 out of 1212 and brood 3: 2 out of 1236) were confirmed as sex-linked recessive lethals. Hence based on the above findings, it can be concluded that sodium hexafluorosilicate did not induce mutations/was not mutagenic in the Drosophila sex-linked recessive lethal assay.