Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Justification for not performing the LLNA:

The registration substance as well as the read-across supporting substances are surfactants.

The experimentally obtained values for the surface tensions are 37.2 mN/m (at 90% saturation concentration and 20°C) for the registration substance and 31.6 mN/m (at 1g/l and 20°C) and 38.2 mN/m (at 90% saturation concentration and 20°C) for the read-across supporting substances.

Justification for read-across using (Pentapropenyl succinimido)-hexanoate, sodium and triethanolamine salt as supporting substance.

The registraton substance is a weak acid and the read-across supporting substance is the corresponding weak base. When dissolved in water the read-across supporting substance will be converted to the registration substance.

Justification for the read-across approach using (Tetrapropenyl succinimido)-caproic acid as supporting substance:

The registration substance and proposed supporting substance are homolog series of (Polypropenyl succinimido)-caproic acid. The only structural difference is that the alkyl moiety of the registratoin substance is composed of five propylen unit, whereas that of the supporting substance is composed of four propylen unit. The given structural difference is not likely to be associated with significantly deviating dermal bioavailability and chemical reactivity. Comparable skin sensitization potentials are expected.

Skin sensitization property of the registration substance

Two read-across supporting substances were investigated according to OECD 406. No significant skin sensitization property was found for both substances. Likewise no significant skin sensitization property can be derived for the registration substance.


Migrated from Short description of key information:
The registration substance is a non-skin sensitizer.

Justification for selection of skin sensitisation endpoint:
Guideline study; well-performed and well-documented; Weight of evidence approach is used.
Two studies are available on read-across supporting substances, which are considered to be equally valid for the assessment.

Justification for classification or non-classification

The skin sensitization potential of the registration substance is assessed based on the data on the read-across supporting substances. In two GPMTs (Guinea Pig Maximization Test), no skin sensitzation property was found. No classification is warranted for the registration substance.