Registration Dossier

Administrative data

Description of key information

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

The acute dermal irritation of ITTFEP (purity 82.3%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Griffon 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute dermal irritation testing in 3 male rabbits (weight of 2762 to 3282 g on day 0) 500 mg test item was administered to the clipped skin. Application was performed for 3 minutes (animal 1) and 4 hours (animals 1 to 3). The untreated skin served as control. The skin were examined according the EU specifications. After a 3 minutes exposure (one animal) no cutanous reactions were observed. After a 4 hour exposure (three animals), a very slight erythema was observed in animal #2. This very slight effect was only observed 1 hour after removing the dressing. There were no remarkable clinical observations during the study. It can be concluded that under the experimental conditions the test substance is non irritant when administered by dermal route to rabbits.

The acute eye irritation of ITTFEP (purity 82.3%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 405 and EU Method B.5 (Griffon 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute eye irritation testing in 3 male rabbits (approx. weight of 3065 to 3571 g at the start of the test) 0.1 mL test item was administered to the conjunctional sac of the left eye after gently pulling the lower lid away from the eyeball. The untreated right eye served as control. The eyes were examined according the EU specifications after addition of fluorescein. Since there was no evidence for irritaion, the test was terminated after 72 hours. Very slight or slight conjunctival reactions including very slight or slight chemosis (grade 1 or 2) and very slight or slight redness of the conjunctiva (grade 1 or 2) were observed on all animals on day 1; these reactions persisted up to day 2 at latest. Mean scores calculated for the three animals over 24, 48, and 72 hours were 0 for coronal opacity, 0 for iris lesions, 0.1 for chemosis and 0.3 for redness of the conjunctiva. There were no remarkable clinical observations during the study. It can be concluded that under the experimental conditions the test substance is non irritant when administered by ocular route to rabbits.

Justification for classification or non-classification

According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to skin or eye.