Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Study duration:
chronic
Species:
rat

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
11.12 mg/kg bw/day
Study duration:
chronic
Species:
rat
Additional information

The NOAEL value is stated as Fluoride and not as zinc hexafluorosilicate.

Justification for classification or non-classification

The available information from repeated dose toxicity studies as well as reproductive toxicity studies do not indicate a hazard for female reproduction in relation to exposure to fluoride. A recent two-generation study focussing on the damage to the male reproductive system, no testicular effects were seen at an exposure level of 250 mg NaF/L. Additionally, it is especially noted that in none of the animal carcinogenicity studies effects on morphology ofany of the reproductive organs were found.