Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

An experimental study (Buehler test, OECD guideline 406) was perfomed to determine the skin sensitization potential of Citronellyl acetate. The substance was applied undiluted (MNIC) under occlusive dressing 3 times at D0, D7, D14 during the sensitization phase for 6 hours each. The animals were challenged at D28 with 100% Citronellyl acetate and the cuteaneous response was evaluated at 24h and 48h after challenge. The control group was sensitzed with 100% liquid paraffin and challenged with 100% Citronellyl acetate (MNIC). At 24 hours after challenge, only one animal in the treated group showed discrete erythema at the site of Citronellyl acetate challenge (=5% of sensitized animals). At 48 hours after challenge, none of the treated or control animals showed signs of cutaneous reaction to Citronellyl acetate.

In an Open Epicutanous Test, reported in literature from review article with limited documentation on results, guinea pigs received 21 daily applications of 0.1 ml citronellyl acetate to the clipped flank for induction (Klecak 1985). At days 21 and 35 after beginning of the induction, challenge applications with citronellyl acetate were performed at concentrations, stated as minimal irritating concentration and respective 3 fold serial dilutions. Citronellyl acetate was reported to be negative under the chosen testing conditions.

In a human maximization test, reported in literature from secondary source with limited documentation, 25 subjects received five occlusive applications of citronellyl acetate for alternate-day 48 h periods (Kligman, 1971). After a ten days rest period, an occlusive 48 h challenge application was done on a fresh site with a concentration of 4% in petrolatum. The evaluation after patch removal and 24 h thereafter revealed no dermal effects. Therefore citronellyl acetate was not sensitizing under the chosen testing conditions.

Migrated from Short description of key information:
- Buehler Test (OECD 406): not sensitizing (BASF 32H0442/03X044, 2014)

Justification for classification or non-classification

The present data on dermal sensitization are not sufficient to fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.