Registration Dossier

Administrative data

Description of key information

Skin Irritation – are not corrosives or dermal irritants
Ocular Irritation - are not ocular irritants
Respiratory Irritation - are not respiratory irritants

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)

Additional information

Skin Irritation - C10-C12 Aromatics are not corrosives or dermal irritants for rabbit (OECD TG 404). Topical application of C10-C12 Aromatics to the clipped backs of rabbits under semi-occlusive dressing for 4 hours elicited dermal responses in all animals. The dermal responses consisted of erythema ranging from very slight to well defined erythema and very slight edema. A total of 14 animal studies were examined that covered all substance in the category. Five studies used occlusive dressing and did not report sufficient data for classification. Eight studies that were of superior quality and used GLP standards reported data which did not lead to classification. C10-C12 Aromatics are not irritating to human skin when evaluated in a repeated patch test as a 50% w/w preparation. Application of a 50% w/w preparation of C10-C12 Aromatics under semi-occlusive conditions did not result in signs of primary irritation. In another study at the same concentration, application of C10-C12 Aromatics to the skin without or in conjunction with UV irradiation did not elicit an irritation response in any of the study participants. Using qualitative weight of evidence reasoning, the C10-C12 Aromatics are not irritating to rabbit or human skin.

 

Ocular Irritation - C10-C12 Aromatics are not ocular irritants (OECD TG 405) when evaluated in rabbits following a single 0.1 ml ocular instillation. Testing of C10-C12 Aromatics generally demonstrated reversible conjunctive redness, chemosis, and infrequent discharge in animals. Draize scores were generally low. A total of 7 studies were examined that covered all substance in the category. All study results indicate that the C10-C12 Aromatics are not irritating for rabbits.

 

Respiratory Irritation - No studies were located to indicate that C10 -C12 Aromatics are respiratory irritants.

 

Justification for classification or non-classification

These findings do not warrant the classification of C10-C12 Aromatics as skin, ocular, or respiratory irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

SKIN IRRITATION: Erythema and edema scores (24, 48, and 72 average) are below the classification threshold requirements: 2.0, Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparation; 2.3, the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP)

 

OCULAR IRRITATION: Ocular lesion scores (24, 48, and 72 average) are below the classification threshold requirements.

Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparation: 0, cornea opacity; 0, iris lesion; >2.5, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis).

Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP): 0, cornea opacity; 0, iris lesion; >2.0, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis).

RESPIRATORY IRRITATION - There are no studies that warrent classification as a respiratory irritant under either the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC or under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).