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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
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 found to be sensitising to skin in a GPMT and in a LLNA.

The following information is available on sensitising properties of AAI substances:

    TO + DETA                            Sensitising: 40% positive reaction in GPMT, i.d. induction 0.1%

    TO + DETA                            Sensitising: LLNA: EC3: 0.3%.

    C16-18, C18 unsat + TEPA   Sensitising: 100% positive reaction in GPMT, i.d. induction 0.1%

    TO + Poly(Amide)                  Sensitising: 100% positive reaction in GPMT, i.d. induction 0.2%

 

Based on the available data, all substances in the AAI group should be considered sensitising to skin.

Classification according to CLP (ATP 2) skin sensitiser: Cat.1A (LLNA: EC 3 = 2%; GPMT = 30% positive at = 0.1% i.d. induction or = 60% positive at >0.1% i.d. induction)

Migrated from Short description of key information:
Based on the available data, all substances in the AAI group should be considered sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Additional information:

There is no information on respiratory sensitisation, but Tall oil + DETA is sensitising by dermal route.

The likelihood for exposure via inhalation and thus becoming sensitised to AAI, is very low, based on the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI).


Migrated from Short description of key information:
No data.

Justification for classification or non-classification

Various studies with different AAI indicate that these substances can cause dermal sensitisation. Tall oil + DETA was found to be sensitising to skin in a GPMT, and in a LLNA, resulting to an EC3 of 0.3% indicating that it should be considered as a strong sensitizer and should be classified as dermal sensitiser Cat.1A for CLP (Criteria ATP 2, Commission Regulation 286/2011 of 10 March 2011).

The actual risk of sensitisation is probably low, as AAI are corrosive to skin and consequently exposure will be low due to necessary protetive measures to limit dermal exposure.

Also the likelihood for exposure via inhalation and thus becoming sensitised to AAI, is very low, based on the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI).