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EC number: 695-748-3 | CAS number: 65286-55-7
An NOAEL of 100 mg/kg bw/day was established in the combined 28 -day repeated dose toxicity study/reproductive toxicity screening study (oral route, OECD 422; Edwards, 2018).
This dose descriptor starting point was therefore used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from oral to inhalation, the modified dose descriptor starting point NOAEC is 176.32 mg/m³ = 100 mg/kg/day x 1/0.38 m³/kg/day x 0.67 x 1. 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 respective conditions (6.7 m³ for base level, 10 m³ for light activity). No additional correction factor is required as the bioavailability after both oral and inhalatory exposure is considered to be 100%.
No reliable acute data is available for the inhalation route of exposure.
No long-term dermal toxicity study is available for the test substance. However, data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening study (OECD 422; Edwards, 2018) could be used after extrapolation to the dermal route. The NOAEL established at 100 mg/kg bw/day was therefore used to derive a DNEL long-term, systemic effects via the dermal route.
For route-to-route extrapolation (oral to dermal), a correction factor of 2 should be applied as part of the overall assessment factor, as it is assumed that bioavailability after oral exposure is 100% and after dermal exposure 50%.
No effect threshold levels were derived for the general population, as no consumer use is expected.
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