3-(isotridecyloxy)propylamine

Endpoint summary

Description of key information

Etheramine C13i was found to be corrosive in BCOP test, and corrosive to rabbit skin follwing 3 minutes exposure.

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

Etheramine C13i induced severe ocular irritation on isolated bovine cornea through, resulting in a mean in vitro irritancy score of 82 after 10 minutes of treatment. As the IVIS is above 55.1, it this means that Etheramine C13i is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test.

There is a Japanese publication on the dermal effects performed with a linear C₁₂-etheramine (3-(Dodecyloxy)propylamine; CAS 7617-74-5) [Nakano Y, 1995] in an in vivo dermal corrosion study on rabbit skin which indicated that 3-lauryl oxy propylene amine is not corrosive. However, the available English translation is very poor in reporting. Also there is doubt on the product tested, as this is described as a solid with a mp of about 65°C, whereasEtheramine C13i is a clear fluid with a mp < -30°C.

ref.: Nakano Y, 1995, Corrositex evaluation on amino compound and pyridino compound, Osaka Prefectural Institute Public Health, Osaka, Japan

Etheramine C13i was tested in an in vitro skin irritation test using a reconstructed human epidermis model (EU method B.46). However, as the substance caused anon-specific MTT reduction > 30% (39% & 41%), it was conclude that this method is not a suitable test method for Etheramine C13i.

Results from the BCOP study indicated that severe effects could be expected following dermal exposure, but as the in vitro dermal irritation study was not technical feasible, an in vivo study was designed specifically to minimize the risk for animal harm. The study was performed in a stepwise manner and started with the treatment of one animal with a stepwise exposure regime.

One rabbit was exposed to three samples of 0.5 mL of Etheramine C13i applied to separate skin-sites on intact, clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed at least once daily for 4 days after treatment and 7 and 14 days after exposure. Based on the severity of the skin reactions, no further animals were exposed.

All exposures resulted up to very slight erythema and oedema in the treated skin areas on day 1, progressing into severe erythema and oedema from 24 hours after exposure on all treated skin sites. The skin irritation remained present up the end of the 14-day observation period and was accompanied by reduced flexibility of the skin between 24 hours and 7 days. A dry wound as well as a bald, noticeable white skin (indicating full thickness destruction of the skin), and superficial redbrown eschar formation was observed at 14-days after exposure on all treated skin sites.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The in vivo dermal corrosion study in rabbits, indicates that Etheramine C13i causes corrosive effects of the skin following 3 minutes exposure, which developed with the course of a week. Consequently, GHS classification 1B is appropriate, with hazard statement H314: Causes severe skin burns and eye damage.

There is no information is available following exposure via inhalation. However, with a vapour pressure of 0.425 Pa at 20 °C, potential for inhalation of vapours is limited. Inhalation of aerosols may cause respiratory irritation due to the corrosive properties of the substance.