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

Respiratory tract
Regarding the sensitising potential of cryolite at the respiratory tract no information is
available. Therefore there is no concern for consumers regarding respiratory sensitisation.
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.
Repeated dose toxicity
Since the relevant consumer exposure scenarios are characterized by inhalation of cryolite
dermal and oral repeated dose toxicity was not further calculated.
Inhalation
The human NOAEC for inhalation is derived from a study in aluminium smelter with longterm
occupational exposure and is given as 0.48 mg fluoride/m 3 for skeletal fluorosis. Animal
data showed dystrophic lesions in bones and teeth and adverse effects in the respiratory tract,
stomach, kidney, liver and brain in a 5-month inhalation study in male and female rats with a
systemic NOAEC of 0.5 mg/m 3 that should be used for risk characterisation.
For the decision on the appropriateness of MOS, the following aspects have been considered
and taken into account
-overall confidence in the data base:
The data taken into account for performing the risk characterisation have been evaluated with
regard to their reliability, relvance and completeness according to section 3.2 of the TGD
-uncertainty arising from the variability in the experimental data:
The data on toxicity after inhalation exposure is sufficient to allow the identification of an
effect level for risk characterisation. There are no reason to assume a special extent of
uncertainty which has to be taken into account.
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.
The nature and severity of the effect:
The observed adverse effects in animals and humans are regard as serious. The systemic
health effects are the basis for the classification as toxic, R48/23/25.
- dose-response relationship:
There is no reason to assume a special concern
The human population to which the information on exposure applies:
following the exposure pattern there is no reason to assume a special risk for children, elderly,
or pregnant women
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