3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-one

Endpoint summary

Description of key information

Ebanol will not be classed as a slight skin and eye irritant.  

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Key Study for Skin Irritation In Vivo (Inveresk Research International - 1985):
After 4 h exposure, very slight erythema (score 1) was noted in one animal at 0.5 h and in all animals at 24 h. Moderate erythema (score 2) was noted in 2 animals at 0.5 h. No oedema was noted in any animals. Very slight to moderate irritant responses to Ebanol were noted. It is concluded that after a 4 h exposure period, Ebanol is slightly irritating to rabbit skin. All observed affects were fully reversible within 48 hours.

Key Study for Eye Irritation In Vivo (Harlan Laboratories - 2010):

The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Within 24 hours, mildly irritant. At 48 hours, minimal irritation. All observed affects were fully reversible within 72 hours.

Key Study for Eye Irritation In Vitro (Harlan Laboratories - 2010): Skinethic reconstituted human corneal epithelium

The Skinethic reconstituted human corneal epithelium model was administered 30µL of neat Ebanol for a 10 minute exposure period.

The optical density and viability data for the negative control and neat Ebanol (30µL) are: Negative control: OD540 = 0.923 and Viability = 100% ; Ebanol: OD540 = 0.921 and Viability = 99.8%. The test material Ebanol was considered to be a Non-Irritant.

Justification for classification or non-classification

Based on the available in vivo skin irritancy study for Ebanol and Polysantol used for read-across, in accordance with 67/548/and 1272/2008/EC, Ebanol is not required to be labelled as a skin irritant.

Based on the available in vivo eye irritancy study for Ebanol, in accordance in accordance with 67/548/and 1272/2008/EC, Ebanol is required to be labelled as an eye irritant. Although the in vitro Skinethic reconstituted human corneal epithelium model gave a negative result for eye irritation, the in vivo study result takes precedence. In addition, in the in vivo study the cornea did not give significant effects which confirms the in vitro negative result. The in vivo significant effects were observed with the conjunctivae (redness, chemosis, discharge).

On the basis that the test substance (Ebanol) is being used to support Ebanone on the basis of read-across, Ebanone is not considered to require classification as a skin and eye irritant.