Registration Dossier

Administrative data

Description of key information

Skin irritation: irritating to the skin (Xi; R38) according to the Directive 67/548/EEC but not classified under the Regulation (EC) No. 1272/2008 (CLP)
Eye irritation: Not classified.
Respiratory irritation: No data.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

A study was identified as the key study (Brenda, 1993). This study was performed according to the EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion) and in compliance with GLP. New Zealand White rabbits were dermally exposed to undiluted Hexyl cinnamic aldehyde (HCA) for 4 hours using a semi-occlusive patch. The mean individual scores calculated within 3 scoring times (24, 48 and 72 hours) were 2/2/2 for erythema and 1.33/1.67/1.67 for oedema. All the reactions were fully reversible within 11 days.

Under the test conditions HCA is classified as irritating to skin (Xi; R38) according to the Directive 67/548/EEC but is not classified under the Regulation (EC) No. 1272/2008 (CLP).

 

The three supporting studies show similar results.

 

Eye irritation:

A study was identified as the key study (Brenda, 1994). This study was performed according to the EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) and in compliance with the GLP.

0.1 mL of undiluted HCA was instilled into the conjunctival sac of male New Zealand White rabbits. Under the test conditions, HCA didn’t induce eye irritation. A transient redness of the conjunctivae was observed in both the 3 tested animals (scores 0.3/0.33/0.33) but was fully reversible within 2 days.

Under the test conditions, HCA is not irritating to eyes.


Effects on skin irritation/corrosion: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

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:

With erythema scores equal 2 in the 3 tested animals, Hexyl cinnamic aldehyde is self-classified as irritating to skin (Xi; R38) according to the criteria of the Annex VI to the Directive 67/548/EC. However HCA is not classified under the Regulation (EC) No 1272/2008.

HCA is not classified for eye irritation.