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

The nature and severity of the effect:
The observed adverse effects in animals are regard as serious. The systemic health effects are
the basis for the proposal of classification as repr. Cat. 3, R63.
- 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
-other factors:
There are no other factors known that might require a particular margin of safety.
MOS for the inhalation exposure scenario, local effects
Inhalation risk assessment will be based on the oral NOAEL of 42 mg cryolite/kg bw/day
from the two-generation rat study. Taken forward to consumers (bodyweight 70 kg) and
taking into acount oral (95%) and inhalation (90%) absorption this value corresponds to an air
concentration for consumers of 3736 mg/m 3 (42 mg/kg bw/day x 0.95/0.9/0.83 m 3 ), assuming
a respiratory volume of 0.83 for consumers in 1 hour shift. The air concentration resembles
the corrected NOAEC.
The margin of safety between the
exposure level of 6.25 mg/m 3
and the
inhalative NOAEC of 3736 mg/m 3
is judged to be sufficient.
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.
Summary of risk characterisation for consumers
Concern is expressed and risk reduction measures should be intiated for consumer use in
pottery. Inhalative repeated dose treatment of cryolite can induced fluorosis at relatively low
doses. Regarding acute toxicity, skin irritation , sensitisation, mutagenicity, carcinogenicity
and reproductive toxcicty no concern is expressed. Due to insufficient data base for eye
irritation conclusion (i) on hold is appropriate.
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