Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine

Endpoint summary

Description of key information

Corrosive properties are observed following exposures of 3 minutes and longer on rabbit skin, with the skin destruction becoming visible the next day.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Dermal irritation:

The skin irritation potential of Oleyl-diamine mono-oleate was determined in a guideline study (OECD 404) performed under GLP.

The possible irritation or corrosion potential of a single dose of Oleyl-diamine mono-oleate administered to the intact skin of rabbit was evaluated in a primary skin irritation study carried out based on the guidelines described in OECD 404 (2015)/OPPTS 870.2500 (1998)/JMAFF Guidelines (2000).
One rabbit was exposed to three samples of 0.5 grams of Oleyl-diamine mono-oleate 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 on the day of dosing (Day 1) and Day 2. Based on the severe skin reactions, no further animals were exposed.

On the day of dosing, up to grade 2 erythema and grade 4 edema was noted for all treated skin sites. Necrosis was noted for all treated skin areas on the day after dosing.

 

Eye irritation:

Due to the corrosive response observed in de dermal irritation/corrosion study with this substance, it is not ethical to carry out this animal study. In view of the severe reactions to skin, serious eye damage is to be expected.

 

Respiratory irritation:

There is no study on respiratory irritation available for Oleyl-diamine mono-oleate.

Oleyl-diamine mono-oleate is a liquid/paste with a vapour pressure less than 0.00087 Pa at 25 °C. Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected.

Justification for classification or non-classification

Available data indicate corrosive properties following exposures of 3 minutes and longer. Following exposures, the skin destruction is observed at examination the next day, but not yet at the observation 1 hour after the exposure. Consequently, GHS classification Corrosive Category 1B is appropriate, with hazard statement H314: Causes severe skin burns and eye damage.

Due to corrosive properties demonstrated in the dermal irritation/corrosion study with this substance, testing in eyes is not justified. Under GHS with the hazard phrase ‘H314 Causes severe skin burns and eye damage’ additional classification for eyes is not necessary. Classification for “Eye Damage 1 - H318: Causes serious eye damage” is implicit.

There is no information is available following exposure via inhalation. However, with a vapour pressure of less than 0.00087 Pa at 25 °C, potential for inhalation of vapours is limited.Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur.Consequently, despite the irritant nature of the substance, respiratory irritation is not expected, and classification STOT-SE Cat.3 for respiratory irritation is not required.