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EC number: 618-561-0
CAS number: 9046-10-0
As no long-term study on inhalation is
available, route-to-route extrapolation has been performed (oral to
The NOAEL (oral route) observed in an Extended One-Generation
Reproductive Toxicity Study, performed according to OECD 443 guideline
(Barnett, 2020), was used to derive a DNEL long-term, systemic effects
via the inhalation route. The NOAEL was established to be 150 mg/kg
bw/day. After route-to-route extrapolation from oral to inhalation, the
dose descriptor starting point is 132.2 mg/m³ = 150 mg/kg bw/day x
1/(0.38 m³/kg bw/day) x 6.7 m³/10 m³ x 0.5. The oral dose for rats was
converted to the corresponding air concentration using a standard
breathing volume for the rat (0.38 m³/kg for 8 hours exposure for
workers). For workers, the resulting air concentration needs to be
additionally corrected for the difference between basal caloric demand
and caloric demand under light activity. This correction factor is
derived from the inhaled volumes in 8 hours under the respective
conditions (6.7 m³ for base level, 10 m³ for light activity). In
addition, the NOAEL needed to be divided by 2 as the bioavailability via
the inhalation route is considered as 100%, while for oral exposure this
is only 50%.
A 90 -day repeated dose toxicity study with dermal application of the
test substance was performed according to GLP requirements and
equivalent to the OECD guideline 411 (Pharmakon Research International
Inc., 1990; key study, Klimisch 2). The NOAEL in this study is
established at 250 mg/kg bw/day. The DNEL for long-term, systemic
effects for the dermal route of exposure was derived with the NOAEL
(dermal) of 250 mg/kg bw/day as dose descriptor starting point.
No consumer use is expected, therefore no hazard assessment for the
general population is performed
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