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:

In the key study (Klimisch score = 2,API 1985b), 10 male Hartley albino guinea pigs were dermally exposed to light catalytically cracked distillate in an induction phase and then a subsequent challenge dose. Undiluted test material was applied under occlusion at a dose volume of 0.4 mL in all instances. One control animal was found dead on day 16. Following the challenge application, very slight erythema was present in three of the nine surviving animals. The other test animals exhibited no reaction following challenge treatment. The naïve control group also exhibited very slight erythema in three of the control animals, indicating a lack of a sensitising response in the treated animals. 

 

In five supporting studies, cracked gas oils were not found to be sensitisers to guinea pigs.

 

Based on these results, cracked gas oils are not skin sensitisers when tested using a closed patch technique in guinea pigs.

 

Migrated from Short description of key information:

Cracked gas oils are not skin sensitisers when tested using a closed patch technique in guinea pigs.

Justification for selection of skin sensitisation endpoint:

One of six studies showing no effect

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Cracked gas oils are not classified as skin sensitisers according to EU CLP Regulation (EC No. 1272/2008) criteria.