Registration Dossier

Administrative data

Description of key information

Di-tridecamine was found to be corrosive to the rabbit skin under occlusive conditions. Dermal application for 1, 5 and 15 min caused severe erythema, edema and very severe scaling of the skin, while after 20-hour exposure and 8 days the skin had a parchment-like necrosis that extends far beyond the area of exposure, the surroundings showed severe erythema and edema.
A single application of undiluted di-tridecamine to the rabbit eye caused corrosion with severe corneal opacity and redness of the eye and very severe edema. Further observations after 24 h: hemorrhages and suppuration.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

In a skin irritation test comparable to OECD guideline 404, di-tridecamine was applied to the skin of Vienna White rabbits for 1, 5, 15 min or 20 hours (using 2 animals at all exposure durations) under occlusive conditions and observed for 8 days (BASF AG, 1970; 1977). Application caused severe erythema extending beyond the area of exposure and distinct edema after 1, 5 and 15 min of exposure. Dermal application for 20 hours induced a parchment-like necrosis that extends far beyond the area of exposure, the surroundings showed severe erythema and edema after 24 hours and after 8 days. Di-tridecamine was judged highly corrosive to the skin.

In addition, two in vitro tests to assess the skin corrosion potential of Tridecanamine, N-tridecyl-, branched and linear were conducted (2018). The studies were carried out to compare the toxicological properties of two batches of the UVCB DTDA.

Two EpiDerm ™ tissues per exposure time were treated with 50 μL undiluted liquid test substance. The tissues were exposed for 3 minutes and 1 hour. For DTDA PSN 18/0020-1 the mean viability after 3 min was 95.1% and 64.2 % after 1 hour exposure. For DTDA PSN 18/0019-1 the mean viability after 3 min was 104.2% and 58.3% after 1 hour exposure.

Based on the results observed and by applying the evaluation criteria, it was concluded that DTDA PSN 18/0020 -1 and DTDA PSN 18/0019 -1 do not show a skin corrosion potential in the EpiDerm TM in vitro skin corrosion test under the test conditions chosen.

However, these results are considered to be false negative due to the very low water solubility of the test substance. Here, the EpiDerm test is not a suitable method to assess the endpoint skin irritation/corrosion for DTDA.

Eye irritation

In an eye irritation test comparable to OECD guideline 405, di-tridecamine was applied to conjunctival sac of the eyes of 2 Vienna White rabbits (BASF AG, 1970). Animals were observed after 1 and 24 hours and up to 8 days after the treatment. The application caused corrosion (not fully reversible), expressed by severe redness and corneal opacity and very severe edema. Di-tridecamine was judged corrosive to the eyes.


Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, di-tridecanamine needs to be classified as corrosive to the skin and eyes according to Directive 67/548/EEC (C, R35) and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1A, assigned H314, causes severe skin burns and eye damage).