Registration Dossier

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Adequacy of study:
other information
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The results of the risk evaluation (see section 9 and 10 of CSR) indicate the need for restrictive risk management measures to control the risk for the dermal route of exposures, therefore we suggest to perform an in vitro skin absorption study (OECD 428) in order to have a more precise indication on undecylenic acid skin absorption as we used a maximum skin absorption factor of 100% for DNEL derivation via the dermal route. The risk evaluation will be therefore fine tuned and more relevant.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
GLP compliance:
yes (incl. certificate)

Results and discussion

Applicant's summary and conclusion