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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published, guideline-comparable study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of cosmetics ingredients licensed by the European Communities
Author:
Gocke E, King MT, Eckhardt K & Wid D
Year:
1981
Bibliographic source:
Mutat Res 90:91-109

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
: small group size
GLP compliance:
no
Remarks:
: older published study
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sodium hexafluorosilicate (Fisher Scientific)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
Two exposures at 0 and 24 hours.
Frequency of treatment:
Animals were dosed at 0 and 24 hours.
Post exposure period:
Bone marrow smears were prepared at 30 hours.
Doses / concentrations
Remarks:
Doses / Concentrations:
37.6 mg/kg bw
Basis:
other: actual
No. of animals per sex per dose:
2/sex
Control animals:
yes

Examinations

Tissues and cell types examined:
Bone marrow erythrocytes

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not examined

Any other information on results incl. tables

No deaths occurred; signs of toxicity are not reported. The proportion of micronucleated PCEs in treated animals is reported to be 2.0/1000, compared to 2.2/1000 in controls. No evidence of mutagencitity was seen under the conditions of this assay.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
No evidence of mutagencitity was seen under the conditions of this assay.
Executive summary:

The genotoxicity of sodium hexafluorosilicate was investigated in a bone marrow micronucleus assay in NMRI mice. Animals (2/sex) were administed two intraperitoneal injections of the test substance at 37.6 mg/kg bw. No evidence of genotoxicity was seen in this study.