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 skin sensitisation potential of the Fatty Acid Polyol with CAS No. 57675-44-2 (2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate) was evaluated in guinea pigs with a Buehler test for skin sensitisation (Key, Cognis, Pittermann, 1994, Skin sensitization, RL2). 20 female Pirbright white; Hsd/Win:DH guinea pigs were treated with the test substance and compared with 10 control animals. Three epidermal inductions were performed with 100 % test substance in weekly intervals for 6 hours under occlusive conditions (cranial shared flank). 14 days after the last induction treatment, the shorn flanks (caudal) of all animals were challenged for 6 hours epicutaneously with 100% test substance (diluted in peanut oil) under occlusive conditions. Animals were evaluated for skin reactions 24, 48 and 72 h after challenge. Slight dermal effects on the right flank were seen in one animal of the test group and one animal of the control group. Effects were reversible within 72 h (control group) or were still apparent at the end of the observation period (72 h).

 

According to the OASIS Database provided from the Danish Environmental Protection Agency and Danish QSAR group, National Food Institute, Technical University of Denmark (DTU) the CAS No. 57675-44-2 (2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate) was predicted to have no skin sensitisation potential (Danish EPA, QSAR prediction skin sensitisation, 2010, RL2).


Migrated from Short description of key information:
Key, Cognis, Pittermann, 1994, Skin sensitization, RL2 – not sensitising
Danish EPA, QSAR prediction skin sensitisation, 2010, RL2 – not sensitising

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data on respiratory sensitisation was available.

Justification for classification or non-classification

According to the DSD and CLP criteria for classification and labelling of dangerous substances CAS No. 57675-44-2 (2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate) is not classified as sensitising.