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:

The first study Keeler (1975) comprised of two methods. Ten Guinea pigs were exposed to the test material in both tests according to methods similar to Buehler (1965) and Maguire (1973), the study provided a sufficient level of detail to assess the accuracy of the data. None of the test animals displayed effects of skin sensitisation according to either method. The second study by Carabello (1976) followed a methodology similar the repeated insult patch test procedure of Draize (1959), exposing 56 human volunteers to the test material. Again none displayed a positive reaction to the test material and it was determined to be non-sensitising.

Both studies were performed to sound scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results. They have thus been assigned a reliability score of 2, according to the principles for assessing data quality set out in Klimisch (1977).


Migrated from Short description of key information:
The skin sensitisation potential of the test material was determined in consideration of three studies performed in line with or adapted from Buehler (1965), Maguire (1973) and Draize (1959). All three studies demonstrated that treatment of the subject with test material did not induce any sensitising effects. As a result, the test material was concluded to be non-sensitising following a weight of evidence approach.

Justification for selection of skin sensitisation endpoint:
The key study was conducted on human volunteers (presented in the Sensistisation data (humans) section) and hence is most relevant for risk assessment purposes.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

SKIN SENSITISATION

The skin sensitisation studies indicate that the test material is non-sensitising and therefore does not require classification under Regulation 1272/2008.