Registration Dossier

Administrative data

Description of key information

In vitro studies for skin and eye irritation were performed with the registered substance as solution in ethyl acetate. In parallel ethyl acetate alone was tested. The effects observed for the test item seem to be based on the irritating properties of the solvent. Therefore, the registered substance will be assessed following the legal classification of ethyl acetate, i.e. as eye irritant but not as skin irritant.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The technical form of the registered substance is a solution in ethyl acetate (ca. 40 % w/w). The solvent free substance solidifies as a glassy but still sticky material. It is not possible to obtain a powdered sample in a mortar for testing and thus, testing of the isolated (pure) registered substance for skin and eye irritation and skin sensitization is technically not feasible. Therefore, and since the solution is the only form humans can come into skin/eye contact with, it was decided to apply the technical product for these toxicological tests. In the in vitro testing for skin and eye irritation the solvent ethyl acetate was tested in parallel to distinguish potential toxicity of the registered substance from solvent toxicity.

The solvent ethyl acetate (CAS-No. 141-78-6) is a slight to moderate skin irritant (GHS criteria not fulfilled). According to Annex VI of CLP Regulation ethyl acetate is classified as eye irritant (GHS Eye Irrit 2). However, according to information provided by REACH registrants (see ECHA homepage) ethyl acetate was found to be only mildly irritating to rabbit eyes in vivo and all effects disappeared within 7 days. The registrants stated that based on these results ethyl acetate does not warrant classification for eye irritation.

The in vitro tests provided here for skin and eye irritation of ethyl acetate (see description below) did not reflect the only mild irritating potential of ethyl acetate as confirmed in vivo. Rather, some of the in vitro tests appeared to be too sensitive resulting in false-positive outcome for skin irritation and severe eye damage. The technical product (consisting of 60 % ethyl acetate and 40 % of the registered substance) showed a comparable, but overall slightly less positive outcome.

The fact that the technical product showed overall less severe effects in the in vitro tests for eye irritation compared to ethyl acetate alone indicates that the registered substance has a lower (or at maximum comparable) irritating potential than ethyl acetate. Therefore it was decided to rely on the available in vivo data for skin and eye irritation of ethyl acetate for classification of the registered substance and not on the in vitro test results that obviously do not reflect the in vivo situation. Consequently the registered substance is not classified for skin irritation but is classified for eye irritation with ‘Eye Irrit 2’.

Justification for classification or non-classification

The technical form of the registered substance, a solution in ethyl acetate (ca. 40 % w/w), is the only form humans can come into skin/eye contact with. Therefore, it was decided to apply the technical product for in vitro testing of skin and eye irritation. The solvent ethyl acetate was tested in parallel to distinguish potential toxicity of the registered substance from solvent toxicity.

The solvent ethyl acetate (CAS-No. 141-78-6) is a slight to moderate skin irritant (GHS criteria not fulfilled). According to Annex VI of CLP Regulation ethyl acetate is classified as eye irritant (GHS Eye Irrit 2). However, according to information provided by REACH registrants (see ECHA homepage) ethyl acetate was found to be only mildly irritating to rabbit eyes in vivo and all effects disappeared within 7 days. The registrants stated that based on these results ethyl acetate does not warrant classification for eye irritation.

The in vitro tests provided here for skin and eye irritation of ethyl acetate (see description below) did not reflect the only mild irritating potential of ethyl acetate as confirmed in vivo. Rather, some of the in vitro tests appeared to be too sensitive resulting in false-positive outcome for skin irritation and severe eye damage. The technical product (consisting of 60 % ethyl acetate and 40 % of the registered substance) showed a comparable, but overall slightly less positive outcome.

The fact that the technical product showed overall less severe effects in the in vitro tests for eye irritation compared to ethyl acetate alone indicates that the registered substance has a lower (or at maximum comparable) irritating potential than ethyl acetate. Therefore it was decided to rely on the available in vivo data for skin and eye irritation of ethyl acetate for classification of the registered substance and not on the in vitro test results that obviously do not reflect the in vivo situation.

Consequently the registered substance is not classified for skin irritation. For eye irritation the legal classification for the solvent ethyl acetate (CAS-No. 141-78 -6) according to EU Regulation 1272/2008 with Eye Irrit 2 (H319) is carried over to the registered substance.