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EC number: 232-188-7 | CAS number: 7789-75-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published study
Data source
Reference
- Reference Type:
- publication
- Title:
- Cytogenetic Studies of sodium fluoride in mice
- Author:
- Zeiger E, Gulati DK, Kaur P, Mohamed AH, Revazova J & Deaton TG
- Year:
- 1 994
- Bibliographic source:
- Mutagenesis, 1994, 9(5), 467
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was performed in the mouse and investigated the incidence of chromosomal aberrations in bone marrow cells and the incidence of micronuclei in erythrocytes.
- GLP compliance:
- not specified
- Type of assay:
- other: combined chromosomal aberration and micronucleus assay
Test material
- Reference substance name:
- Sodium fluoride
- EC Number:
- 231-667-8
- EC Name:
- Sodium fluoride
- Cas Number:
- 7681-49-4
- IUPAC Name:
- sodium fluoride
- Test material form:
- not specified
- Details on test material:
- No further details
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No further information given.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- The test substance was administered in the water.
- Details on exposure:
- The cytogenetic effects of sodium fluoride (NaF) were measured in mice following administration in the drinking water for 6 weeks.
- Duration of treatment / exposure:
- Sodium fluoride was administered in the drinking water for 6 weeks.
- Frequency of treatment:
- Sodium fluoride, administered in the drinking water was available ad libitum for 6 weeks.
- Post exposure period:
- No post exposure period.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 400 mg/L
Basis:
nominal in water
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- A concurrent positive control was used.
Examinations
- Tissues and cell types examined:
- Micronuclei were measured in peripheral blood erythrocytes following 1 and 6 weeks of administration. Bone marrow cell preparations were examined for the presence of chromosome aberrations following 6 weeks of treatment.
- Details of tissue and slide preparation:
- Micronuclei were measured in peripheral blood erythrocytes following 1 and 6 weeks of NaF administration. Bone marrow cell preparations were examined for the presence of chromosome aberrations following 6 weeks of treatment; metaphase and anaphase cells were examined. Anaphase cells were scored in three independent laboratories, two of which also scored metaphase cells from the same slides.
- Evaluation criteria:
- No evaluation criteria.
- Statistics:
- Not relevant
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- No evidence of micronuclei in erythrocytes or chromosomal aberrations in bone marrow cells.
- Toxicity:
- yes
- Remarks:
- Mortality at 400 mg/L; bodyweight effects at 200 and 400 mg/L
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Bone fluoride levels were determined and showed a dose-related incorporation of fluoride. No increases in micronuclei were seen in peripheral erythrocytes at either time point, and no increases in chromosome aberrations were seen in bone marrow cells when metaphase or anaphase cells were examined.
Any other information on results incl. tables
Bone fluoride levels were determined and showed a dose-related incorporation of fluoride. No increases in micronuclei were seen in peripheral erythrocytes at either time point, and no increases in chromosome aberrations were seen in bone marrow cells when metaphase or anaphase cells were examined. A concurrent positive control, cyclophosphamide, produced significant increases in peripheral blood cell micronuclei and in chromosome aberrations in bone marrow cells in metaphase. No increases in aberrations were seen in the same cyclophosphamide-treated mice when anaphase cells were examined.
Applicant's summary and conclusion
- Conclusions:
- Sodium fluoride did not cause any cytogenetic effects in mice under the conditions of this study
- Executive summary:
The potential for sodium fluoride to cause chromosomal effects was investigated in a drinking-water study in mice. Mice were exposed for 1 or 6 weeks to sdoium fluoride. No evidence of micronuclei formation was seen in peripheral blood erythrocytes afer 1 or 6 weeks; no evidence of chromosomal aberration was seen in bone marrow cells after exposure for 6 weeks. Marked toxicity (including mortality) was seen at the highest dose level in this study.
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