Pyridine, 2-chloro-3-(2,2,2-trifluoroethoxy)-

Endpoint summary

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 CTFEP (purity 91.4%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 404 and EU Method B.4 (Griffon 2000). 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 (approx. weight of 2591 to 2854 g on day 1) 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), except for a brown coloration of the skin which could have masked a very slight erythema on day 1, no cutanous reactions were observed. After a 4 hour exposure (three animals), a very slight erythema was observed in all animals on day 1, it persisted in one of them up to day 3. 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.

 

According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item is not required to be classified as irritating to the skin.

The acute eye irritation of CTFEP (purity 91.4%) 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 2777 to 2920g at the start of the test) 100 mg 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. Two animals showed no adverse reaction after addition of the test item within 72 hours and were subsequently sacrificed. For the third animal slight chemosis (grade 2), very slight redness of the conjunctivae (grade 1) and clear discharge were observed on day 1; very slight chemosis (grade 1) persisted up to day 7. In this animal alopecia was also recorded between day 2 and 10. Mean scores calculated for the three animals over 24, 48, and 72 hours were 0 for coronal opacity, 0 for iris lesions, 0.4 for chemosis and 0 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.

 

According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item is not required to be classified as irritating to the eye.

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.