Registration Dossier

Administrative data

Description of key information

There is no information from sensitisation studies available. Being an UVCB with low solubility and high Pow makes the substance out of domain for the standard in vitro tests for skin sensitisation. An in vivo skin sensitisation study does not need to be conducted as the substance is classified as corrosive to the skin.

There are no reports on incidents of sensitisation to alkyl ether diamines available.

Profiling and QSARs indicate a low risk for sensitization, and cross-reading to primary alkylamines indicates non-sensitising properties.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Etherdiamine C13i/acetate is corrosive. As indicated in REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted if the substance is classified as corrosive to the skin.

 

In vitro testing will not provide adequate information as Etherdiamine C13i/acetate is out of domain for in vitro assaysbased on UVCB properties, insufficient level of solubility and high logP (> 5,KOWWIN). (However, it should be remarked that Pow of the cationic surfactants are pH dependent, a property that makes them especially adsorbing and accumulating in phospholipid membranes also making adequacy of in vitro testing doubtful. The actual measured Pow is -0.4)

 

Considering its structure, none of the profilers in OECD Toolbox (v.4.4) trigger an alert relevant to protein binding and sensitisation. The primary amine is likely the most determining substructure of the substance with respect to possible development of sensitisation. For the category of primary alkylamines as presented in the EU RAR, all are evaluated as to be non-sensitising. Cross-reading with the category primary alkylamines seems most appropriate for this substance. (Ref.EU risk assessment under 93/793/EEC as published by ECHA in the annex XV REACH transitional documents). The QSAR Toolbox (v.4.4) skin metabolism simulator predicts possible deamination of terminal amine. However, generally the primary amines are stable and this doesn’t seem a likely route, which also indicates that Etherdiamine C13i/ is not likely a pro-hapten.

 

QSARs show some mixed results. DEREK concludes that skin sensitisation in mammal is plausible, because of the diamine structure within the structure of Etherdiamine C13i. The DEREK report indicates that this is based on a number of diamines that are borderline moderate-strong skin sensitisers and are mainly used as epoxy resin hardeners. However, compared to this etherdiamine, these are smaller structures, not based on a long alkyl chain.

Some other QSARs like VEGA (CAESAR 2.1.6) conclude to possible sensitisation (moderate reliability). This QSAR than also indicates that secondary amine structures are basically lacking in the training set.

Further, it should be remarked that published articles in peer reviewed journals clearly demonstrated that irritants and surfactants are more likely to give rise to false positives in the LLNA. As cationic surfactants result to false positive results in LLNA studies, results from LLNA studies on cationic surfactant structures should not be included the development of QSARs. In that respect the QSARs are not clear whether such LLNA results were included in their development.

 

Due to use in industrial setting only, with the application of adequate PPE related to the severe corrosive properties ofEtherdiamine C13i/acetate, exposures are limited.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Likelihood of exposures via inhalation is low considering the high boiling point (> 300 °C) and low vapour pressure (0.005 Pa at 25°C). Possible exposures are therefore only possible in the form of aerosols.

Useis in industrial setting only, in applications without specific risks for aerosol forming.

With the lack of sensitising properties suggested by profiling, QSAR and from read-across to fatty amines in general, the risks for respiratory sensitisation is low. Besides, the substance is classified as severe corrosive, leading to respiratory irritation upon exposures via inhalation likely before sufficient exposures can be reached to develop sensitisation via inhalation.

Justification for classification or non-classification

There is no information available from testing, so definitive data is lacking. However, concerns for sensitisation are low as the potential for exposures are low as use is limited to industrial settings under controlled conditions. Furthermore, profiling , QSAR and cross reading with primary alkylamines indicates that the substance is not sensitising.