Phenethyl acetate

Endpoint summary

Description of key information

The skin irritation study reports only minor transient effects.  Although there is a lack of detail in reporting, the results are supported by the presence of minimal effects in the acute dermal toxicity study at dose levels well in excess of the limit dose.  It can therefore be concluded that phenylethyl acetate does not require classification as a skin irritant.  Although relatively mild signs of eye irritation seen in a rabbit study are not of sufficient magnitude to trigger classification, the absence of any evidence of reversibility within the 7-day study period triggers classification as a Category 1 eye irritant according to the CLP criteria.

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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro assessment of skin irritation or corrosivity potential was not required since in vivo administration of three doses to rabbits revealed 24 hour exposure to phenylethyl acetate at 6500, 10000 or 15000 mg/kg elicited no more than transient very slight erythema that resolved rapidly.

The key study of irritation also demonstrated a lack of dermal reactions. In a group of eight rabbits treated with phenylethyl acetate for 4 hours under a semi-occlusive dressing, marginal or slight erythema and oedema were observed up to 24 hours after dosing but reactions had reversed within 72 hours.

No in vitro assessment of ocular irritation/corrosivity was necessary since the in vivo study indicated persistent ocular reactions in rabbits that would necessitate classification as 'Risk of serious damage to eyes'. Despite ocular reactions not being very severe, and the mean scores over the 24 -72 hour period would not exceed classification thresholds, but the study was terminated on day 7 and reactions persisted in the rabbits at the time of termination. Since reversibility could not be confirmed, it is necessary to default to the Cat.1 classification for eye irritation under Regulation 1272/2008, 2nd ATP (Commission Regulation (EU) No. 286/2011 of 10 March 2011). This equates to the R41 "risk of serious damage to eyes" classification under the DPD.

Justification for selection of skin irritation / corrosion endpoint:

Only one standard study available for this endpoint

Justification for selection of eye irritation endpoint:

Only one study available

Effects on eye irritation: highly irritating

Justification for classification or non-classification

There is no indication from a skin irritation study or from an acute dermal toxicity study that phenyl ethyl acetate requires classification as a skin irritant. The absence of reversibility in the eye irritation study warrants classification of phenyl ethyl acetate as a Category 1 eye irritant according to CLP criteria, H318 causes serious eye damage.