Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because skin contact in production and/or use is not likely
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex VIII, section 8.5.3, column 2 of Regulation No. 1907/2006, testing by the dermal route is appropriate if skin contact in production and/ or use is likely and the physiological and toxicological properties suggest potential for a significant rate of absorption through the skin. Dermal exposure during use of 4-aminobenzoyl-b-alanine as an intermediate is unlikely due to the risk mitigation measures in place in the pharmaceutical facility and that all processes are performed in accordance with Good Manufacturing Practices. Furthermore, studies on the physical and chemical properties of 4-aminobenzoyl-b-alanine have shown that the water solubility is 11.75 g/L and the partition coefficient (log Kow) is -1.19. According to REACH Endpoint Specific Guidance Chapter R.7c, substances with a water solubility above 10,000 mg/L and a log Kow value below 0, may be too hydrophilic to cross the lipid rich environment of the stratum corneum and hence dermal uptake for these substances will be low. Therefore, for these reasons, the performance of an acute dermal study on 4-aminobenzoyl-b-alanine is considered scientifically unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion