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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 dermal sensitization study (Hüls AG, 1987) with p-tert-butyltoluene (purity 99.53%) in maize germ oil, young adult Pirbright White guinea pigs (20 females in the test group; 10 females in the control group) were tested using the method of Magnusson and Kligman (Guinea pig maximization test according to OECD TG 406; intradermal induction at 20%; epicutaneous induction with the undiluted compound; challenge at 50%; no data on positive control material).

After challenge, skin reactions were seen in 0/20 test animals and in 0/10 control animals at both the 24- and 48-hour reading. Local reactions (irritation signs) were limited to irritation at the sites treated with FCA by intracutaneous injection and topical application; erythema, edema, slight necrosis, and eschar formation were recorded in both test and control animals. There were no general reactions during the investigation, and the treatment had no serious influence on the increase in body weight. At the sites treated with maize germ oil (vehicle control), slight erythema and edema was noted at the injection sites.

In this study, p-tert-butyltoluene is not a dermal sensitizer.

Migrated from Short description of key information:
Not sensitizing (guinea pig maximization test) (Hüls AG, 1987).

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
no data

Justification for classification or non-classification

There is no need to classify 4-tert-butyltoluene for skin sensitization according to the Directive 67/548/EC or GHS criteria.