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 skin sensitisation studies conducted for the Fatty Acid Polyol with the CAS No. 85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol). Data from studies of structural analogues, conducted according to OECD Guideline 406 (Buehler Test) and OECD Guideline 429 (Local Lymph Node Assay), were used for read-across.

 

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, Lees, 1991, Croda, Skin sens., 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.

Furthermore, a Local Lymph Node Assay was conducted with the same substance (CAS No. 68424-31-7, Fatty acids, C5-10, esters with pentaerythritol). The test substance was applied in concentrations of 3%, 10% and 30% on three consecutive days to the dorsum of both ears of 4 female CBA/Ca mice each. Five days later the animals received approx. 20 µCi of 3H-methly thymidine and were sacrificed 5 h later for measurement of radioactivity. No significant increase in isotope incorporation was detected after repeated application. The stimulation index, calculated by comparison of the Cpm of the control and the treated animals, was 0.45 for the 3% application, 2.05 for 10% and 1.21 for the 30% application (RA-S, CAS 68424-31-7, Key, Robinson, 1991, Croda, Skin sens., RL2).

 


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

The available data from structural analogue substances does not indicate a potential for skin sensitisation.

According to the DSD and CLP criteria for classification and labelling of dangerous substances CAS No. 85116-93-4 (Fatty acids, C16-18, esters with pentaerythritol) is not classified as sensitising to the skin.