Registration Dossier

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:
other: Information on major hydrolysis product of the registered substance (released rapidly on contact with water/moisture).
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well designed in vivo study published in a peer-reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Sodium fluoride and chromosome damage (in vitro human lymphocyte and in vivo micronucleus assays)
Author:
Albanese R.
Year:
1987
Bibliographic source:
Mutagenesis vol.2 no.6 pp.497-499

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
Rats dosed orally, bone marrow erythrocytes scored for micronuclei.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Analar quality NaF.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
90-140g bodyweight

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Distilled water
Details on exposure:
Single oral dose
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
500 mg/kg
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
5 for each sampling time
Control animals:
yes
Positive control(s):
Cyclophosphamide

Examinations

Tissues and cell types examined:
Bone marrow cells
Details of tissue and slide preparation:
Paintbrush smears
Evaluation criteria:
Micronucleated cells recorded in 2000 polychromatic erythrocytes (PEs)
Normochromatic erythrocytes (NEs) in 1000 PEs recorded.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Remarks:
4/5 rats dosed at 1000 mg/kg died before the 48h sampling time
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
NE/PE ratio was close to 1 in vehicle control and NaF treated groups, giving no indication of bone marrow toxicity.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
No evidence of chromosome-damaging activity was detected in this in vivo study.