Registration Dossier

Administrative data

Description of key information

The substance caused temporary mild transient reactions in rabbit eyes and no irritating reactions on rabbit skin. Both studies followed the procedure outline in OECD testing guideline 405 and 404 with minor deviations. Findings in eyes are sufficiently mild that no hazard classification is needed.

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

The studies for skin and eye irritation of the test substance were performed under the principles of GLP. Their design is comparable to that of the respective OECD testing guidelines with some deviations. These include determination of the body weight at the end of the study, the shorter observation period and testing of both intact and abraded skin. Since all findings healed within the short observation period, the deviations are considered acceptable. The test item is only described by code, information on purity is not available in the report. Overall, sufficient information is given to assign these studies the status of key studies. Draize scores were 0 for erythema and edema in the skin irriation study. In the eye irritation study, one of three animals showed mild iritis, which healed within 48h. All three animals showed mild effects on conjunctivae below the threshold of significance which healed within 72h.

The studies for skin and eye irritation of the dodecyloxy analogue were performed prior to the introduction of OECD testing guidelines and GLP. As such, they have some limitations in reporting details referring to the test item and the housing conditions. The observation period is limited to 72h post treatment. In this case, it is acceptable since no indication of an irritating effect was observed. The test item is only described by a company code; information on purity is not available in the report.

No experimental data is available regarding respiratory irritation.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin irritation and for eye irritation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.