Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

2,3 -Epoxypropyl neodecanoate was evaluated for dermal sensitizing potential in four independent guinea pig Maximization studies following the methods established by Magnusson and Kligman (Magnusson, B. and Kligman, A. M., 1969. The identificaz.ion of contact allergens by animal assay. The guinea—pig maximization test. J. Invest. Derm., 52, 268—276). One of the Maximization studies was conducted according to the current O.E.C.D. Testing Guideline 406, "Skin Sensitization" protocol under the GLP regulations. The level of positive skin reactions observed in challenged test guinea pigs ranged from 45% to 95%. Therefore, 2,3 -epoxypropyl neodecanoate is a Moderate to Extreme dermal sensitizer in the guinea pig Maximization test.


Migrated from Short description of key information:
2,3-Epoxypropyl neodecanoate was assessed for dermal sensitization in four independent guinea pig Maximization tests. The findings from these studies demonastrated that 2,3-epoxypropyl neodecanoate is a Moderate to Extreme skin sensitizer in the guina pig.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No study data is available regarding respiratory sensitization potential. No worker exposure reports have been made.


Migrated from Short description of key information:
No data

Justification for classification or non-classification

Based on findings from multiple guinea pig Maximization dermal sensitization tests, 2,3 -epoxypropyl neodecanoate meets the criteria for Classification as a skin sensitizer.