Registration Dossier

Administrative data

Description of key information

No test data available. Profiling and QSARs indicate a low risk for sensitisation, and due to use in industrial and professional setting only, with the application of adequate PPE related to the severe corrosive properties of the diamines, exposures are limited. There are no reports on incidents of sensitisation to diamines available.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The profiling of alkyl-diamines (QSAR Toolbox v.4.1) indicates that no alerts are found for protein binding, thiol reactivity is not expected, and that the structure is not represented among the categories of high, moderate or low reactivity in DPRA (direct peptide reactivity assays) for either cysteine or lysine depletion. Additionally, the molecular structure of the diamines does not contain toxicophores indicating a concern for sensitization, and also read across to data available on structurally related branched triamine (Dodecyl dipropylene triamine) and primary amines in general do not indicate a concern.

(The automated workflow in QSAR Toolbox for sensitisation results to a positive prediction, which is based on cross-reading to a single positive GPMT result from decanol, and a negative LLNA for 1,14-Tetradecanediol. As both substances are not even amine structures, this prediction is not considered valid)

Information from QSARs:

- VEGA (Skin Sensitisation model (CAESAR) version 2.1.6): Predicts sensitizer, but with low validity: it indicates that the substance is out of model Applicability Domain and that there are no similar compounds in the training set. (All listed positive structures are not amines)

- DEREK (Derek Nexus: 3.0.1, Nexus: 1.5.0): predicts that skin sensitisation is plausible. This is based on observation of sensitisation to diamine as diaminoethane, ethyleneamines and 3-aminopropyldimethylamine. These are not considered to be predictive to the cationic surfactant diamines.

- TOPKAT (Accelrys ADMET Toxicity Prediction (Extensible)) predicts non-sensitizer, with highest reliability for longer (C18) chain length.

 

There are no reports on incidences of sensitisation from industrial production and use of the substance.

 

For a comparable structure (C12-triamine Y) a guinea pig study (OECD 406 - Buehler) study is available, which confirms non-sensitizing properties. Also read-across to data derived from animal testing available for the structurally related primary amines do not indicate a concern.

(For information on the applicability of the read-across from various diamines, see document "Category polyamines - 20170518.pdf" added to IUCLID Ch. 13.)

 

As indicated under skin corrosion/irritation, the skin reactions have a large inflammatory component. These inflammatory reactions lead to local lymph node growth at extreme low concentrations, suggesting of a very potent sensitisation reaction, although the few available data involving guinea pig studies (on other cationic surfactants do not show increased reactions upon challenge. Finally, also for polyamine products used as biocide, there are no specific concerns for sensitisation following handling or use.

 

Discussion: dermal

There is no data on sensitisation available for (Z)-N-9-octadecenylpropane-1,3-diamine (Oleyl-diamine). Available studies indicate that Oleyl-diamine is highly corrosive. There are no consumer exposures, only industrial/professional use under circumstances involving the use of PPM following its classification as corrosive cat. 1B. Consequently, due to limited exposures, animal testing is not required.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

(Z)-N-9-octadecenyl-1,3-diaminopropane (Oleyl diamine) is a liquid/paste with a vapour pressure of less than 0.0015 Pa at 20°C. Its use is limited to industrial and professional users and does not involve the forming of aerosols, particles or droplets of an inhalable size. So exposure to humans via the inhalation route will be unlikely to occur.Additionally, information from profiling for expected protein interaction and QSARs for sensitisation result to a low concern.

Justification for classification or non-classification

Based on limited exposures by dermal route (substance is severely corrosive) or by inhalation (very low vapour pressure) and a low concern based on profiling for expected protein interaction and QSARs for sensitisation, sensitisation is not expected to be an issue.

However, as a firm conclusion from a study with this compound is lacking, no definite conclusion might be drawn for classification purposes.