Registration Dossier
Registration Dossier
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EC number: 680-341-5 | CAS number: 41438-38-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Absorption rate - dermal (%):
- 32.5
Additional information
According to data available by oral route in the acute oral toxicity study at 2000 mg/kg bw and in developmental toxicity study (OECD 414) at doses of 100, 300 and 1000 mg/kg bw/day, MEXORYL SBU can be considered as without any toxic effect.
In vitro skin penetration of MEXORYL SBU was performed through human dermatomed skin and rat full thickness skin over a 24 hour exposure period with a formulation containing a nominal 5 % MEXORYL SBU.
The results obtained in this study indicate that MEXORYL SBU penetrated through human and rat skin at a slow rate from a 5 % MEXORYL SBU test preparation. The extent of penetration through human and rat skin amounted to 27.9 % (140μg/cm2) and 20.4 % (102μg/cm2), respectively after 24 hours.
For both human and rat skin, a large proportion of the applied dose remained on the skin surface after a 24 hour exposure interval and was readily removed by a gentle skin washing procedure. Low proportions of the dose were associated with the stratum corneum and remaining epidermal membranes.
The total systemically available value (epidermis plus dermis and receptor fluid) was similar for human and rat skin and represented 32.5 % and 32.4 % of the applied dose, respectively (corresponding to 162μg/cm² and 162μg/cm², respectively). Considering that the dermal penetration decrease with the increase of the concentration, the 32.5% of dermal penetration obtained with preparation at 5% was considered as conservative value to evaluate the skin penetration of Mexoryl SBU.
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