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EC number: 639-566-4
CAS number: 165184-98-5
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).
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.
harmonized classification is available according to the Regulation (EC)
No 1272/2008 including ATP1.
- May cause sensitisation by skin contact
(Xi; R43) according to the criteria of the Annex VI of the Directive
- 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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