Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Available information indicates that all AAI subsatnces are 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

As explained in the category justification, For cross-reading in general use is made with data of same or lower EA-length where available, and that of Tall oil + DETA representing the worst case. This dossier is for the substance "Fatty acids C16-18 and C18-unsatd., reaction products with tetraethylenepentamine”. As for the substance itself no toxicological information is available, cross-reading has been applied to TO + DETA.

Tall oil + DETA was evaluated in an in vivo dermal irritation/corrosion study in rabbits
The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test item was irritant but not corrosive on this first animal, it was then applied for 4 hours to only one other animal. As the test item showed corrosive properties on this second animal, the study was considered complete and the test item was not evaluated on a third animal. The study concluded that Tall oil + DETA is corrosive to rabbit skin after 4 hours exposure.

 

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:

    TO + DETA                           in vivo: Corrosive: Cat.1C

    TO + 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 two available sensitisation studies on Tall oil + DETA.

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 0.5% in corn oil. Epidermal concentrations of 1% resulted to signs of superficial necrosis.

In a local lymph node assay (LLNA) the substance evoked at 0.5% dissolved in acetone/olive oil (4/1, v/v) some slightly irritant effects following epidermal application of 25µg on the ears of mice. At 0.25% no irritation was observed.

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

Tall oil + DETA 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.