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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Peer reviewed publication
Extensive testing has been performed on chromium and fluoride salts; since dissociation will occur if ingested, assessment of the ions is considered a valid approach. No further animal testing is justified.

Data source

Reference
Reference Type:
publication
Title:
Developmental toxicity of sodium fluoride in rats
Author:
Collins TF et al
Year:
1995
Bibliographic source:
Food Chem Toxicol. 1995 Nov;33(11):951-60

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Principles of method if other than guideline:
Pregnant rats were dosed with different concentrations of sodium fluoride in drinking water up to levels considered to be tolerated.
The viablity and physical form of foeti was examined.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium fluoride
EC Number:
231-667-8
EC Name:
Sodium fluoride
Cas Number:
7681-49-4
Molecular formula:
FNa
IUPAC Name:
sodium fluoride

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Treatment started after mating
Duration of treatment / exposure:
From mating to study termination prior to birth
Frequency of treatment:
Drinking water
Control animals:
yes, concurrent vehicle
Details on study design:
0, 10, 25, 100, 175 or 250 ppm NaF daily throughout gestation
(0, 1.4, 3.9, 15.6, 24.7 and 25.1 mg/kg body weight)

Examinations

Maternal examinations:
Yes
Ovaries and uterine content:
Yes
Fetal examinations:
Yes

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Food consumption decreased significantly at the top dose (ca 25 mg/kg/day) and body weights of pregnant females were reduced accordingly suggesting upper level of tolerance
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Food consumption decreased significantly at the top dose (ca 25 mg/kg/day) and body weights were reduced accordingly suggesting upper level of tolerance
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Food consumption decreased significantly at the top dose (ca 25 mg/kg/day) and body weights were reduced accordingly suggesting upper level of tolerance
Water consumption and compound intake (if drinking water study):
effects observed, treatment-related
Description (incidence and severity):
Water consumption decreased significantly at the top dose (ca 25 mg/kg/day)

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
not examined
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined
Changes in number of pregnant:
no effects observed
Description (incidence and severity):
There was a reduction in implants per littler in the top group, although the final number of viable foeti were not significantly different accross the groups.

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEC
Effect level:
ca. 25 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain

Maternal abnormalities

Abnormalities:
no effects observed

Results (fetuses)

Fetal body weight changes:
no effects observed
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
not specified
Changes in litter size and weights:
no effects observed
Description (incidence and severity):
Not significant, but reduced implants in high dose group
Changes in postnatal survival:
not examined
External malformations:
no effects observed
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Increased incidence in bone formation in top group, but not considered significant
Visceral malformations:
no effects observed
Description (incidence and severity):
No soft tissue variations

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEC
Effect level:
> 25 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Remarks on result:
not determinable due to absence of adverse toxic effects

Fetal abnormalities

Key result
Abnormalities:
no effects observed

Overall developmental toxicity

Key result
Developmental effects observed:
no

Applicant's summary and conclusion

Conclusions:
No significant adverse effects on development, although some observatiobns of skelatal effects at highest maternal treatment group.

Other review documents do not consider fluoride salts to have any developmental toxicity effects.