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EC number: 947-751-9 | CAS number: -
The relevant dose descriptor selected to derive the inhalation DNEL, was the lowest oral rat NOAEL of 233.4 mg/kg bw/day derived from an OECD combined repeated dose toxicity study with the reproduction/developmental toxicity screening study conducted with the read across substance, isodecyl oleate (i.e., a substance representing the constituent isoalkylester). This dose descriptor which is the starting point was corrected for route-to-route extrapolation:
[i.e., NOAEL oral rat ÷ SRvrat x (SRvhuman ÷ WSRvhuman) x (ABSoral-rat/ABSinh-human) x days per week(experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 233.4 mg/kg bw/d; SRvrat = 0.38 m3/kg bw; SRvhuman = 6.7 m3; WSRvhuman = 10 m3; ABSoral-rat = 50%; ABSinh-human = 100%; days per week(experimental) = 7 days; days per week (human population) = 5 days for workers) = 233.4 x 1/0.38 x 6.7/10 x 7/5 x 50/100 = 288.06 mg/m3]
[i.e., NOAEL oral rat x (ABSoral-rat/ABSderm-human) x days per week(experimental)/days per week(human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 233.4 mg/kg bw/d; ABSoral-rat = 50%; ABSderm-human = 50%; days per week(experimental) = 7 days; days per week(human population) = 5 days for workers) = 233.4 x 7/5 x 50/50 = 1400 mg/kg bw/day]).
No DNELs for general population have been derived as no REACH-relevant consumer use has been identified. The only consumer use is as cosmetic products, which are not within the scope of REACH.
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