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EC number: 200-864-0
CAS number: 75-35-4
Calculation of the T25:
Calculation of net tumor incidence:
Net tumor incidence (%) = % Tum.(T) - %
Tum.(C) / [ 100% - % Tum.(C) ]
Correction for standard lifespan:
- Study duration: 105 wks
- Standard lifespan: 104 wks
Corrected dose = 99.12 * 105 / 104 = 100.07 mg/m3
Calculation of T25:
T25 = corrected dose * 25% tumor incidence
/ net tumor incidence
Modifications of the dose descriptor:
- Differences in inhalation absorption: no correction
- Route-to-route extrapolation: no correction
- Correction factor for workers (light activity) = 6.7 m3/
10 m3= 0.67
- Correction factor for exposure conditions = (6h/8h) * (52wk/48wk)*
(75y/40y) = 1.5
8h daily exposure for workers vs. 6h testing conditions
48 wk/year exposure for workers vs. 52wk/year testing conditions
75y human lifetime vs. 40y operational exposure
Modified dose descriptor:
T25 = 112.00 mg/m3
The LC50 value (28350 mg/m3)
from the acute inhalation study with rats by Zeller and Klimish (1979)
was selected for the point of departure. To obtain the corrected LC50
value, the following aspects were taken into consideration:
Closed systems are used for the production and industrial use of
1,1-dichloroethene. Therefore dermal exposure of workers to
1,1-dichloroethene is unlikely. A dermal DNEL was nevertheless derived
to provide a guidance value in case such figure would be necessary in
some particular (currently not considered) cases.
No chronic dermal exposure studies are available allowing the
direct calculation of a DNEL. Therefore a route-to-route extrapolation
was performed based on the key value (NOAELoral
9 mg/kg bw/d) from a chronic oral study (Quast et al. 1983,
24h/day, exposure 7 days/week, 24 months treatment period).
In order to introduce a sufficient degree of conservatism in the
approach the following assumptions were made:
However, because the very high volatility of the substance, a
conservative assumption was made that 50% of the applied substance would
not be available for absorption due to evaporation leading to a NOAELdermal
of 18 mg/kg bw / d. This assumption is supported by the data of
Dilling (1977) and by the observation made by Fasano et al. (2008) which
mention that the evaporation of the substance significantly hindered the
in vitro dermal absorption experiments.
The corrected NOAEL of 18.9 mg/kg
was obtained by considering the e exposure regime (24h/day, 7days/week
versus 8h/day, 5 days/week).
Corrected NOAEL = 18 mg/kg bw * (24h / 8h) * (7d / 5d) = 75.6
See derivation of the workers inhalation systemic DMEL.
- Difference in respiratory volume: no correction
- Correction factor for exposure conditions = (6h/24h) * (5d/7d) = 0.179
24h daily exposure for the general population vs. 6h testing conditions
7d/wk exposure for the general population vs. 5d/wk testing conditions
T25 = 19.90 mg/m3
DNEL derivation was performed starting from the
key value (NOAEL oral 9 mg/kg) from the chronic oral study by
Quast et al. 1983.
No modification of the dose descriptor required.
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