Strategy For Limiting Risks Human Health Draft of ... - ECHA - Europa

and the analog sodium fluoride (NTP studies). Due to negative and equivocal test results with
synthetic cryolite and sodium fluoride there is no concern for carcinogenicity. The RAR on
HF concluded that fluoride is not a carcinogenic substance.Therefore the handling of cryolite
regarding carcinogenicity is safe for consumers.
Conclusion (ii) There is at present no need for further information and/or testing and
for risk reduction measures beyond those which are being applied
already.
Toxicity for reproduction
Effects on fertility
There is no indication for fertility risks caused by cryolite, therefore there is no concern for
consumers. A quantitative risk characterisation is not necessary.
Conclusion (ii) There is at present no need for further information and/or testing and
for risk reduction measures beyond those which are being applied
already.
Developmental toxicity
Cryolite was investigated for prenatal developmental toxicity in rats, mice and rabbits with
the oral route of administration. During the two-generation study with rats, administering 0,
14, 42, 128 mg cryolite/kg bw/day in the diet, growth retardation in postnatal development
was observed. Because this effect occured without any significant sign for systemic toxicity it
is considered indicative for a specific toxic potential of cryolite adverse to postnatal
development. The respective NOAEL in the diet study was 42 mg cryolite/kg bw/day. This
value is taken for risk characterisation and used for MOS calculation.
For the decision on the appropriateness of MOS, the following aspects have been considered
and taken into account.
-overall confidence in the database:
The data taken into account for performing the risk characterisation have been evaluated with
regard to their reliability, relevance and completeness according to section 3.2 of the TGD.
Most of the animal data are citations from the secondary literature. The orginal data are not
available. Due to the developmental effects described the proposal to classify cryolite as Repr.
Cat 3, R63 is justified.
-uncertainty arising from the variability in the experimental data:
There are no reasons to assume a special extent of uncertainty
-intra- and interspecies variation:
Available data do not allow a conclusion on the intraspecies or interspecies variability of the
toxicokinetic or toxicodynamic characteristics of cryolite under consideration.
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