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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation assays in vivo in rabbits: non irritant.

Eye irritation assays in vivo in rabbits: non 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

Skin and eye irritation studies on test substance were not available. Therefore, a read-across approach was followed and available studies on RA Substance 01 and RA Substance 02 were used in the assessment.

In particular, RA Substance 01 is a copper complex and shares most of its structure with target substance (all 3 constituents) except for a small portion, which may possibly be released upon cleavage of an azo bond. RA Substance 02 was used to account for possible effects caused by this portion, based on its structural similarity.

A detailed description of the read across approach is attached in section 13.

As for dermal application, two available studies on rabbits exposed to RA Substance 01 reported no evidence of erythema or oedema 24, 48, and 72 hours after patch removal upon a 4-hour exposure period, except for a barely perceptible erythema in one animal at the 24-hour observation time.

As for eye instillation, available studies with RA Substance 01 on rabbits reported minimal conjuctival irritation in terms of redness and/or chemosis, which resolved by the 72-hour observation period, either in case of rinsed eye or not.

In order to complete the assessment, available data on RA Substance 02 was taken into account. In particular, no sign of skin irritation was found in an in vitro test in human epidermal model and no significant ocular effects were reported in rabbits exposed for 21 days, once daily.

Under the test conditions, during the observation period, RA Substance 01 and RA Substance 02 did not induce systemic toxicity nor mortality.

Justification for classification or non-classification

Based on findings in in vivo / in vitro studies on RA Substance 01 and RA Substance 02, no classification within the CLP Regulation (EC 1272/2008) was applied.

In particular, as for skin irritation, the key study (1983) reported mean scores for erythema and oedema over 24 h, 48 h and 72 h below the threshold for classification, i.e. 2.3, in all animals tested.

As for eye irritation, scores averaged over 24, 48 and 72 hours for all animals in the key study (1983) were below the thresholds for classification, i.e. 1 for cornea and iris, and 2 for conjuctivae redness and chemosis.

These findings were confirmed by supporting studies where:

- RA Substance 01 was assessed for skin and eye irritation potential in 2 rabbits;

- RA Substance 02 was tested for skin irritation on human epidermal model and for eye irritation in rabbits upon daily exposure up to 21 days.

On these bases, target substance was considered as non irritant to skin and eye.