Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Theoreitcal assessment
Adequacy of study:
weight of evidence

Data source

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Theoretical assessmnet of toxicokinetic properties
GLP compliance:
no

Results and discussion

Applicant's summary and conclusion

Conclusions:
Conclusion

Based on the common metabolism and enzymatic description, it is considered justifiable to apply results from the epoxidised oil ETP to Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters for the derivation of critical endpoints.

The read across justification for a non toxic epoxidised natural ester and an unsaturated natural ester is proposed through the low toxicity of a central epoxidised unsaturated ester compared to a central unsaturated alkene.

The toxicity profile of the 2-ethyl hexyl ester structural component which is identical for both the EDT epoxy and the Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters was demonstrated as having low toxicity from the EDT data.