Registration Dossier

Administrative data

Description of key information

Skin irritation scores according to Draize (testing procedure being comparable to OECD Guideline 404, skin contact 24 hrs with occlusion): primary irritation score for intact skin 0.5 (Key study: Worstmann, 1980)

Skin irritation scores according to Draize (testing procedure being comparable to OECD Guideline 404, skin contact 24 hrs with occlusion): primary irritation score for intact skin 2.125 (supporting study: Marzin, 1978)

Eye irritation potential (testing procedure comparable to OECD Guideline 405): no effects (Key study: Worstmann, 1980; supporting study: Marzin, 1978; Worstmann, 1980)

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

Skin irritation

Two skin irritation studies are available that applied test protocols similar to OECD Guideline 404 except for the more severe condition of a 24 hr skin contact under an occlusive dressing and an observation period limited to 72 hrs after the start of exposure (Marzin, 1978; Worstmann, 1980). Based on the slight signs of irritation reported at the end of exposure and the tendency of the skin effects to be reversible within the next 48 hrs, these studies can be used as key studies to make a conclusion on the classification of skin irritation. As, even under these more severe exposure conditions, only 1 from 4 rabbits (Marzin, 1978) or none from 6 rabbits (Worstmann, 1980) had mean irritation scores (mean for 24 -72 hrs) for erythema or oedema > 2.3, no classification results based on the criteria of EU Directive 1272/2008.

Eye irritation

Under test conditions comparable to OECD Guideline 405, acetophenone had no irritating effect on rabbit eyes (Key study: Worstmann, 1980; supporting study: Marzin, 1978). Indications of a possible irritation effect on rabbit eyes were reported in old, insufficiently documented studies (Smyth and Carpenter, 1944; Carpenter and Smyth, 1946), that are not comparable to the guideline conditions of the key studies and are therefore not adequate for classification. The more recent studies leading to no irritation are superseding the old study (quoted as reliability 4 according to Klimisch criteria) having lead to DSD Annex I classification as Xi R36.


Justification for selection of skin irritation / corrosion endpoint:
Comparable to guideline study with acceptable deviations, sufficiently documented; study acceptable as key study ((quoted as reliability 2 according to Klimisch)

Justification for selection of eye irritation endpoint:
Comparable to guideline study with sufficient documentation; study acceptable as key study (quoted as reliability 1 according to Klimisch)

Justification for classification or non-classification

According to EU regulation 1272/2008 no classification for skin irritation is justified, as mean irritation scores for erythema or oedema were significantly below the critical value of 2.3 even with a prolonged contact time of 24 hrs instead of the standard 4 hrs.

According to EU regulation1272/2008 there is no classification for eye irritation as no significant eye changes were observed in the key studies.

However as acetophenone is classified as Eye Irrit. 2 H319 in Annex VI of CLP Regulation, it shall be classified and labelled in accordance with this harmonised classification.