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 a valid standard skin sensitisation study conducted by Auletta (1981) using the method of Buehler (similar to OECD 406), the skin of 20 guinea pigs was topically treated with 50% butyraldehyde in acetone 6 hours /day, 3 days/week for 3 weeks. 16 days later the animals were challenged with 10% butyraldehyde (also epicutaneously) and again 1 week later with 25% test substance in acetone. There were no reactions at the 10% challenge, while 2/20 animals exhibited some reactions with minimal erythema. There was no irritation observed in the 10 and 25% initiation controls.

The results suggest that butyraldehyde has only low potential for induction of dermal sensitisation.

In the study conducted by Hoechst Celanese Corporation (1988), when Dunkin Hartley Guinea pigs were exposed to challenge at either 10 or 25% butyraldehyde, no animals reacted at 10% butyraldehyde and 2 animals showed positive reactions when treated at 25% butyraldehyde. On the basis of these results, butyraldehyde exhibits little or no potential to produce dermal sensitization in the guinea pig and as such, does not require classification.

The key study was determined to be the study conducted by Auletta (1981) as it was considered to be the strongest methodologically and adhered to the relevant Guidelines.

Migrated from Short description of key information:
Two skin sensitisation studies are available, both of which use the Guinea Pigs as the test species, specifically the Hartley strain. One of the studies was conducted using a Guideline similar to OECD Guideline 406.

Justification for classification or non-classification

Based on the results of the key study by Auletta (1981), the test substance was not considered to be a skin sensitiser and as such, does not require classification according to Directive 67/548/EEC or Regulation 1272/2008/EC.