Registration Dossier
Registration Dossier
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EC number: 213-367-9 | CAS number: 939-97-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
There is valid information available concerning the skin sensitization potential of p-tert-butylbenzaldehyde, however, no key study can be defined.
The sensitizing capacity of p-tert-butylbenzaldehyde was investigated in guinea pigs and also in human volunteers.
One of the experimental results demonstrates a negative result for p-tert-butylbenzaldehyde, in an open epicutaneous test using guinea pigs (3-4 animals/group). Induction was performed by repeated epicutaneous application (daily for 21 days) using 3, 10 or 30% p-tert-butylbenzaldehyde in ethanol or undiluted p-tert-butylbenzaldehyde. Challenge was performed using a 10% solution on the 21th and 35th day at 30 % (Givaudan 1980 OET). No skin sensitization reactions were observed in this test setup.
Another study (Freuds Complete Adjuvans Test) demonstrated as skin sensitizing potential of p-tert-butylbenzaldehyde. Following intradermal induction (0.1 ml 5 % emulsion in Freund's complete adjuvant on days 0, 2, 4, and 7), sensitizing effects were seen in 3/6 animals after the epicutaneous challenge on the 21st and 35th day at a concentration of 0.3 %, and in 6/6 animals at concentration of l, 3 and 10 % (Givaudan 1980 FCAT).
Concerning human studies, there is no evidence for sensitising capacity of the test substance. In a human repeated insult patch test, 51 volunteers received ten 24-hour occlusive applications of 2% p-tert-butylbenzaldehyde (about 200 mg) in dimethylphthalate over a period of three weeks (Givaundan 1979). After a resting period of 10 -14 days, a single occlusive dermal 24 hours challenge application (2% in dimethylphtalate) was performed. No dermal reactions were observed in the 51 volunteers, providing evidence for the absence of skin sensitizing properties under the chosen testing conditions.
Overall in a weight of evidence, p-tert-butylbenzaldehyde is considered to be a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No information is available.
Migrated from Short description of key information:
No information is available
Justification for classification or non-classification
The present data on dermal sensitization fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a classification with R43 and "Skin sensitisation" (Category 1) is warranted.
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