2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

Endpoint summary

Description of key information

To assess the irritancy potential of the mixed mixed Perfluoralkylethylacrylate to the skin an acute dermal irritation/corrosion toxicity study was performed in the New Zealand White rabbit according to OECD 404. Based on the results of this study  the test substance is regarded as not irritant to the skin.

To assess the irritancy potential of the mixed mixed Perfluoralkylethylacrylate to the eye an acute eye irritation toxicity study was performed in the New Zealand White rabbit according to OECD 405. Based on the results of this study  the test substance is regarded as not irritant to the eye.

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:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits did not produce any erythema or any oedema at all reading time points (i.e. 30 to 60 minutes, 24, 48 and 72 hours). In a second study the skin of 6 rabbits was occlusive exposed to the test item for 24 hours. In this test the test item produced slight erythema (score 1) with no edema in two rabbits and no dermal erythema or edema in four rabbits by 24 and 48 hours following application. By 72 hours, no dermal irritation was observed in the treated rabbits. Comparable results for dermal irritation were obtained with the read across substance in an OECD 404 study where the overall irritation score was determined to be 0.11.

Eye:

A single application of the test substance to the eye of three rabbits produced a slight conjunctivae reddening in all three animals at the 1-hour observation after instillation. At the 1 -hour observation a white to yellowish discharge were observed in one eye. The conjunctivae reddening persists as slight up to the 24-hour reading in two animals and was full reversible at the 48 -hour reading. No changes were observed at the corneal opacity, the iris, and chemosis of the conjunctivae at any time points (i.e. 30- 60 minutes, 24, 48 and 72 hours).

In an acute irritation study according to OECD 405 performed with the read across substance the individual mean scores for corneal opacity, conjunctival chemosis and changes of the iris were 0.00 for all three animals. The individual mean scores for the concunctivae reddening were 0.00, 0.33 and 0.00. The overall irritation score was determined to be 0.08.

In conclusion it is demonstrated that the registration substance as well as the read across substance have a similar low potential for skin and eye irritation.

Justification for classification or non-classification

According to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS (Global Harmonized System for classification, labeling and packaging) Annex 1, the test substance has not to be classified as skin or eye irritant.