Registration Dossier

Administrative data

Description of key information

In in vitro studies conducted according to OECD 439 and OECD 437, the substance was not irritating to skin or eyes (BSL Bioservice, 2014a, b and c).

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 irritation:

A comparison has been made of the predictive powers for organosilicate substances of two reconstituted three-dimensional human skin models, EPISKIN-SM™ and EPIDERM, in OECD 439 studies. It has been concluded that one of the skin models tends to over predict skin irritation for these substances and the other tends to under predict. Therefore 2-(perfluorohexyl)ethyl]trimethoxysilane has been tested in both EPISKIN and EPIDERM. The results of both studies were negative, so it is concluded that the registered substance is not irritating to skin.

2-(perfluorohexyl)ethyl]trimethoxysilane has been tested in two reliable in vitro studies for skin irritation conducted according to OECD 439 and in compliance with GLP using EPISKIN-SM tissue (BSL Bioservice, 2014a) and EPIDERM (MatTek) (BSL Bioservice, 2014b). The mean tissue viability of the test-item treated tissues was not reduced relative to the negative controls in either tissue. The positive control produced the expected reduction in viability. It is concluded that the test item is not irritant under the conditions of the tests.

Eye irritation:

The eye irritancy potential of [2-(perfluorohexyl)ethyl]trimethoxysilane has been investigated in a valid in vitro bovine corneal opacity and permeability assay conducted in accordance with OECD 437 and in compliance with GLP (BSL Bioservice 2014c). The following mean in vitro irritation score was calculated: 0.27. The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. It is concluded that the test substance is not irritating to the eye.

Justification for classification or non-classification

Based on the available in vitro data [2-(perfluorohexyl)ethyl]trimethoxysilane does not require classification for skin or eye irritation according to Regulation (EC) No 1272/2008.