Registration Dossier

Administrative data

Description of key information

The substance is non irritatant to the skin and eye of rabbits.

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

No data on the target substance was available, thus a read across approach was followed. Available data on Similar Substance 01 was used in the assessment. Details on the read across approach are attached in section 13.

Local changes induced by test substance at the site of contact, namely skin and eye, were evaluated irrespective of whether the substance may become systemically available or not. Skin and eye irritation potentials were tested on rabbits by topical application and instillation, respectively.

As for dermal application, very slight erythema was noted after 24 h on both intact and abraded skin in 2/6 and 3/6 rabbits, respectively. Such signs were no more evident at the 72 h observation time point. No signs of oedema were noted over the whole observation period.

As for eye instillation, no effects on cornea and iris were seen. Slight effects on conjuctivae were seen in both rinsed and unrinsed eye, with lower frequency in rabbits with rinsed eye. Such effects were reversible within 6 days.

Under test conditions, during the observation period, the substance did not induce systemic toxicity nor mortality.

Justification for classification or non-classification

Relying on a read across approach, Disperse Orange 061 is not classified according to the CLP Regulation (EC 1272/2008).

As for skin irritation, mean scores for erythema and oedema over 24 h, 48 h (not measured, assumed to be equal to the highest value between 24 and 72 h) and 72 h were below the threshold for classification, i.e. 2.3, in all animals tested.

As for eye irritation, average scores over 24, 48 and 72 hours for all animals were below the thresholds for classification, i.e. 1 for cornea and iris, and 2 for conjuctivae redness and chemosis.