Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Alpha-hexyl cinnamaldehyde is recommended as positive control in skin sensitisation studies under OECD Guideline 406 (Skin Sensitisation) and OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay). As such, alpha-hexylcinnamaldehyde is recognised as a skin sensitiser and extensive data on its response in the LLNA are available. Herein, three study records have been included. They have been selected for inclusion in this endpoint on the basis of what the Research Institute of Fragrance Materials (RIFM) and the International Fragrance Regulatory Association (IFRA) have used to set the IFRA Standard for alpha-hexylcinnamaldehyde for its use in fragrances. This IFRA Standard is presented as an attachment in this endpoint summary.

The EC3 (amount of chemical that induce a simulation index of 3) derived were in the range 6.6-11.5% which correspond to 1650 -2875 µg/cm2 considering:

- an applied dose-volume of 25 µL

- an estimated application area of 1 cm2 for the mouse ear.

A NESIL / NOAEL of 23600 µg/cm2 (highest concentration tested with no sensitisation in human) was obtained in the Human Repeated Insult Patch Test (HRIPT) conducted by the RIFM (see section 7.10.4).  

Although there is not a good agreement between LLNA EC3 and NOAEL derived from HRIPT studies, the HRIPT NOAEL was considered sufficiently robust and relevant as the study is conducted in human to override the EC3 value. Indeed the HRIPT was conducted according to Good Clinical Practice and following the RIFM standard test method.

Therefore, for the derivation of human local dermal DNEL the results of the HRIPT are used. Further justification on the derivation of the local dermal DNEL is provided in the summary under section 7, Toxicological Information.


Migrated from Short description of key information:
The key information for classification is a published study reporting the results of 5 separate experimental LLNA with hexylcinnamaldehyde. The tests have been conducted under a protocol equivalent to OECD Guideline 429 for Local Lymph Node Assay. The EC3 derived was in the range 6.6-11.5%.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
Respiratory sensitisation is not a requirement for this tonnage level. In addition, there is no data available for inclusion under this endpoint.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP1.

Self-classification:

- May cause sensitisation by skin contact (Xi; R43) according to the criteria of the Annex VI of the Directive 67/548/EEC

- Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the criteria of the Annex VI of hte Regulation (EC) No. 1272/2008 (CLP).

This is based on SI>3 and calculated EC3 (6.6 -11.5%) as reported in the key study. Under the categorisation of chemicals according to skin sensitisation potency using the LLNA, alpha-hexylcinnamaldehyde is a moderate skin sensitiser (Potency Values from the Local Lymph Node Assay: Application to Classification, Labelling and Risk Assessment. ECETOC Document No. 46, December 2008).