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:

There were no studies conducted for the Fatty Acid Polyol with the CAS No 15834-04-5 (2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate). Data from a study of a structural analogue, conducted according to OECD Guideline 406 (Buehler Test) was used for read-across. Additionally, the OASIS Database provided from the Danish Environmental Protection Agency and Danish QSAR group, National Food Institute, Technical University of Denmark (DTU) was used to assess the sensitization potential by QSAR prediction. 

 

The skin sensitization potential of the Fatty Acid Polyol with CAS No. 68424-31-7 (Fatty acids, C5-10, esters with pentaerythritol) was evaluated in guinea pigs with a Buehler test for skin sensitisation (RA-S, CAS 68424-31-7, Key, Lees, 1991, Croda, Skin sens., Buehler, RL2). 20 male albino 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. 14 days after the last induction treatment, all animals were challenged for 6 hours epicutaneously with 100% (left shorn flank) and 30% (right shorn flank) test substance (diluted in corn oil) under occlusive conditions. Animals were evaluated for skin reactions 24 and 48 h after challenge. No signs for irritation or sensitisation were observed during induction and challenge of the animals.

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. 15834-04-5 (2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate) was predicted to have no skin sensitization potential (Danish EPA, QSAR prediction skin sensitization, 2010, RL2).


Migrated from Short description of key information:
RA-S, CAS 68424-31-7, Key, Lees, 1991, Croda, Skin sens., Buehler, RL2 – not sensitizing

Danish EPA, QSAR prediction skin sensitization, 2010, RL2 – not sensitizing

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 15834-04-5 (2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate) is not classified as sensitizing.