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

is also some concern with respect to developmental toxicity. In this case the combination of
inhalation and dermal exposure results in concern for one scenario which is not at risk in the
route-specific assessments (see table 2.5). For acute toxicity, respiratory irritation, skin
irritation, respiratory sensitisation, mutagenicity and fertility no concern is expressed. Due to
insufficient data base for eye irritation conclusion i (on hold) is expressed.
Table 2.5 Endpoint-specific overall conclusions for the occupational risk assessment of
cryolite
Toxicological endpoints concern
Acute toxicity
Irritation/ Corrosivity
Sensitisation
Repeated dose toxicity
inhalation ii
dermal ii
combined ii
dermal ii
eye i (on hold)
acute respiratory tract ii
skin ii
respiratory ii
local, inhalation iii
local, dermal ii
systemic, inhalation iii
systemic, dermal iii
systemic, combined iii (1)
Mutagenicity ii
Carcinogenicity
Fertility impairment
Developmental toxicity
inhalation ii
dermal ii
combined ii
inhalation ii
dermal ii
combined ii
inhalation iii
dermal iii
combined iii
(1) conclusion iii already results from dermal exposure and/or inhalation, therefore no specific concern for the
combined exposure scenario is indicated
Risk estimation is based either upon epidemiological studies of certain working populations
exposed to cryolite or on long-term inhalation studies with cryolite dust (rats). For oral
absorption of fluoride a value of 95 % is used and for the inhalation route 90% is taken, both
on the background of experimental data. For dermal absorption a value of 10% is assumed to
be reasonable, however, reliable data are not available.
26