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EC number: 230-528-9
CAS number: 7173-62-8
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.
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.
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.
(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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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