Registration Dossier

Administrative data

Description of key information

Skin sensitisation (Bühler equivalent to OECD TG 406): not skin sensitizing (RIFM 1993)

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In the chosen key study, a Buehler test equivalent to OECD guideline 406 was conducted with male and female Hartley guinea pigs. For induction, a 0.3 ml aliquot of 50% rose oxide in diethyl phthalate (DEP) was placed under occlusion to the clipped left shoulder for 6 hours. This procedure was repeated at the same site, once a week for the next 2 weeks, until a total of 3 exposures were applied. After a 2-week rest period, 0.5, 1.5, and 5% test substance in DEP were applied to previously untreated sites for 6 hours under occlusion. No skin sensitization was observed for rose oxide under the chosen testing conditions (RIFM 1993).

Three studies with human volunteers from secondary sources with limited information are available. In an RIPT, 9 dermal applications for induction and 1 challenge application of 1.25 % rose oxide in ethanol resulted in 0/40 sensitization reactions (IFF 1964). Ten dermal induction applications followed by a single dermal challenge application of 5% rose oxide in dimthylphtalate resulted in dermal reactions in 5/51 volunteers (Givaudan 1965). The relevance of the observed skin reactions for skin sensitization cannot be assessed. In a human maximization test, application of 2% rose oxide in petrolatum did not result in skin sensitization reactions in 25 volunteers (Kligman 1978).

Overall, based on the key study (Bühler test in guinea pigs) and the majority of scarcly reported human test data, rose oxide is found to show no skin sensitization potential.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data available

Justification for classification or non-classification

The present data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and CLP, and therefore, a non-classification is warranted.