Registration Dossier

Administrative data

Description of key information

non-skin irritant

non-eye 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

Since no data is available for the evaluation of the skin and eye irritation potential of the substance, experimental data on analogue substances were taken into consideration. Justification for Read Across is given in Section 13 of IUCLID.

Skin irritation

The irritation potential of Similar Substance 01 to the skin of rabbits was assessed in tests similar/equivalent to the OECD Guideline 404. Male and female New Zealand white rabbits were dermally exposed to the substance diluted in polyethylene glycol. The back of the animals was shaved and abraded and the substance was applied to both intact and abraded skin in an occlusive coverage. After 24 hours of exposure the substance was removed and the animals were observed for 72 hours and scored for signs of erythema and edema. In the Key study, the mean scores (mean over 24 and 72 hrs) were 0.09 and 0.6 at the intact skin for erythema and edema respectively. Both erythema and edema were reversible within 48 hours.

Eye irritation

The eye irritation potential of Similar Substance 02 to rabbits was assessed according to a test similar/equivalent to the OECD Guideline 405. 100 mg of the substance was applied in the one eye of six New Zealand White rabbits; the untreated eye was used as a control. After 30 seconds of the substance application the eyes of three animals were rinsed with warm water while the remaining three eyes were left unwashed. The eyes were observed for 72 hours and signs in cornea iris and conjunctiva (chemosis, redness, discharge) were scored after 1, 6, 24, 48 and 72 hours. The mean score (1 -24 -48 -72 hrs) for cornea opacity and iris was 0; mean score (1 h) for conjuctivae chemosis was 1.6 (fully reversible within 6 hrs) and mean score (6 -24 hrs) for conjuctivae redness was 0.33 (fully reversible within 48 hours). Based on the available results, the substance is considered as a non-eye irritant to rabbits.

Justification for classification or non-classification

Skin irritation

The erythema and edema score obtained in the study are as follows:

- mean score (mean over 24 and 72 hours) was 0.09 and 0.6 at the intact skin for erythema and edema respectively. Both erythema and edema were reversible within 72 hours.

Based on the scores mentioned above for edema and erythema the substance is considered as non-skin irritant, according to the CLP Regulation (EC) No. 1272/2008.

Eye irritation

The scores obtained in the eye irritation study are as follows:

- mean score (1 -24 -48 -72 hrs) for cornea opacity and iris was 0; mean score (1 h) for conjuctivae chemosis was 1.6 (fully reversible within 6 hrs) and mean score (6 -24 hrs) for conjuctivae redeness was 0.33 (fully reversible within 48 hours).

Based on the scores obtained for iris, cornea opacity, conjuctivae redness and chemosis the substance is considered as non-eye irritant, according to the CLP Regulation (EC) No. 1272/2008.