Fatty acids, C18 unsat, reaction products with triethylenetetramin, tetraethylenepentamine and pentaethylenehexamine

Endpoint summary

Description of key information

Available information indicates that Fatty acids C18 unsat, reaction products with tetraethylenepentamine  is corrosive to skin.

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

Fatty acids C18 unsat, reaction products with tetraethylenepentamine was evaluated in an in vivo dermal irritation/corrosion study in rabbits according OECD 404 and performed under GLP. In total 9 New Zealand white rabbits were dermally exposed under semi-occlusion to 0.5ml of the undiluted test substance. 6 rabbits were first exposed for 3 minutes on their left flank, 7 days later the same animals were exposed on their right flank for 1 hour. The other three animals were exposed for 4 hours on their left flank. After exposure the test substance was removed by gentle swabbing with cotton wool soaked in distilled water. Obervations were made at 1, 24, 48, 72 hours and after 7 days. The animals exposed for 4 hours were observed up to 14 days. After 3 minutes exposure slight effects were observed and these were reversible after 7 days. Irritation was observed after the 1 hour exposure and these effects were not revesible within 7 days. The test material produced evidence of visible necrosis following an exposure period of up to four hours and no rceovery was observed within 14 days. Based on this study the test substance should be regarded as corrosive to skin.

 

Also other in vivo irritation/corrosion studies indicate corrosion to skin following 4 hour application. The table below provides an overview of all available for the group of AAI: 

Fatty acids C18 unsat + DETA	in vivo: Corrosive: Cat.1C
Fatty acids C18 unsat + TEPA	in vivo: Corrosive: Cat.1C
C16-18, C18 unsat + TEPA	in vivo: Corrosive: Cat.1C

 

An indication for possible threshold effects for irritation comes from an available sensitisation study on Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine.

In a Guinea pig maximization study for dermal sensitization, a preliminary irritation study evaluated irritation from epidermal exposures to the substance for 24 hrs under occlusion. The highest non-irritating concentration for epidermal exposures was established at 1% in 0.9% NaCl. Epidermal concentrations of 5% resulted to moderate and confluent erythema.

 

There are no eye irritation studies available on an AAI substance. Corrosion to the eye is expected based on dermal corrosion.

There are no data from inhalation studies. However, exposure by inhalation is not likely considering the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI). Furthermore, as the substance is classified as corrosive, no acute toxicity testing should normally be conducted.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Fatty acids C18 unsat, reaction products with tetraethylenepentamine is corrosive to rabbit skin after 4 hours exposure. Consequently, it should be classified Corrosive, Cat. 1C .

Corrosive to eyes is assumed for substances for which dermal corrosion has been established and no additional classification is required.

 

There is no data from inhalation studies. However, in view of the very low vapour pressure of AAI in general, exposure by inhalation is not likely.