Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not irritating

Eye irritation: slightly irritating but not classify

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:
adverse effect observed (irritating)

Additional information

1- Skin irritation / corrosion:

Two studies were available with reliability 1 and 2 according to Klimisch rating (Kr).

- A key study was identified (Tuffnell, 1992). This study was performed similarly to the OECD test guideline No. 404 and in compliance with GLP (Kr: 1). Six New Zealand rabbits were dermally exposed to 0.5 g of ITC 288/S moistened with 0.5 ml of distilled water for 4 hours under an semi-occlusive dressing. Animals were observed for 3 days. Irritation was scored by the draize Scale. All treated skin sites appeared normal after treatment. Mean scores (24, 48, 72 hours) was 0.0 for erythema and edema. Therefore, ITC 288/S is considered as not irritating to the skin.

- A study report (Cuthbert and Jackson, 1991) has been chosen as supporting study. This study was performed similarly to the OECD test guideline No. 404 and in compliance with GLP (Kr: 2). Three New Zealand rabbits were dermally exposed to 0.5 mL of ITC 288/S. Test sites were covered with an semi-occlusive dressing for 4 hours and were washed after the patch removal. Animals were observed for 3 days. Irritation was scored using the OECD Recommended Scoring System. Mean scores per animal (24, 48 and 72 hours) was 0.0 for erythema and edema

Taken together these results show that ITC 288/S is not irritating to the skin

2- Eye irritation:

One study was available for this endpoint and considered as the key study (Tuffnell, 1992). This study was performed similarly to the OECD test guideline No. 405 and in compliance with GLP (Kr: 1), 0.1 mL of ITC 288/S was instilled into the conjunctival sac of the right eye of six New Zealand rabbits. The eyes of the animals were not rinsed after instillation. Changes were observed at 1, 24, 48 and 72 hours after dosing and grading according to Draize scale. ITC 288/S produced chemosis (mean score 0.55), conjunctival redness (mean score 0.83), corneal lesions (mean score 0.28) and iridial lesions (mean score 0.17) which were completely reversed after 3 days. Thus, ITC 288/S is considered as slightly irritating to the eyes.

3- Respiratory irritation:

No data was available.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

1- Skin irritation / corrosion:

As no signs of irritation were observed in two dermal irritation studies with ITC 288/S conducted similarly to OECD test guideline No. 404 (Mean scores (24, 48 and 72 hours) were 0.0 for erythema and edema), ITC 288/S is not classified as irritating to the skin according to the EU legislation (Directive 67/548/EEC and the CLP Regulation (1272/2008)).

2- Eye irritation:

ITC 288/S is slightly irritating to the eyes in a primary eye irritation study conducted similarly to OECD test guideline No. 405. Mean scores (24, 48 and 72 hours) were 0.55, 0.83, 0.28 and 0.17 for chemosis, conjunctival redness, corneal lesions and iridial lesions respectively. All these effects were completely reversed after 3 days. Therefore, no classification is required according to the EU legislation (Directive 67/548/EEC and the CLP Regulation (1272/2008)).

3- Respiratory irritation:

No classification is possible due to lack of data