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EC number: 230-528-9
CAS number: 7173-62-8
Corrosive properties are observed
following exposures of 3 minutes and longer, with the skin destruction
becoming visible after some delay.
Table 1: Dermal irritation of animal 1 and 2
2 additional test
* : necrosis covering half the patch area
Acute dermal irritation/corrosion of
N-Oleyl-1,3-diaminopropane (liquid) was investigated. 0.5mL of the test
substance were applied via a semiocclusive gauze patch to intact clipped
skin of one female New Zealand White rabbit and held in place for 4h. At
the end of the exposure period, residual test item was rinsed with tap
water. In an additional test 0.5mL were applied via a gauze patch to
intact clipped skin of another female New Zealand White rabbit and held
in place manually for only 3min without subsequent rinsing. Animals were
examined for signs of erythema and oedema at 1, 24, 48, 72h after patch
Calculation of Primary Irritation
Scores (PIS) as an average value over 24h, 48h and 72h was calculated
for each animal. This yielded values of 8 for both animals. Necrosis was
observed after 24h in both animals. Irritant effects were not reversible
and occurred as early as 3min after exposure (additional test) and
persisted. 1 Animal displayed weight loss during the observation period.
The symptoms after a contact period of both 4h or 3min required
euthanisation of the animals due to animal welfare reasons shortly after
the end of the 72h observation period.
Considering the reported data of this
irritation study it can be stated that the test item
N-Oleyl-1,3-diaminopropane showed severely irritant effects. According
to the EC criteria for classification and labelling requirements for
dangerous substances and preparations (Guidelines in Commission
Directive 2001/59/EC) the test item N-Oleyl-1,3-diaminopropane has to be
classified as corrosive and has obligatory labelling requirement for
The test on acute dermal
irritation/corrosion was performed under GLP and similar to
guideline OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500
The skin irritation potential of
(Z)-N-9-octadecenyl-1,3-diaminopropane (Oleyl diamine) was determined in
three guideline studies (OECD 404) performed under GLP. The two most
recent studies were performed with different physical states of the
substance i.e. liquid and paste, however with only minor differences in
the composition. The study performed on the liquid had a slightly higher
content of diamines (92.3%) relative to the study performed on the paste
(86.2%). However, this difference is not expected to have an impact on
the outcome of the studies. Both studies indicated relatively severe
necrotic effects that were non-reversible within 72 hours. The oldest
study was performed on a substance with a diamine content of 93.6%. This
study also demonstrated relatively severe corrosivity. The overall
results indicate that (Z)-N-9-octadecenyl-1,3-diaminopropane is
corrosive in skin. Following 3 minute application, necrosis was visible
the next day, but not yet at one hour after exposure.
Due to the corrosive response observed
in de dermal irritation/corrosion studies with this substance it is not
ethical to carry out this animal study. In view of the severe reactions
to skin, serious eye damage is to be expected.
There is no study on respiratory
irritation available forOleyl diamine.
Oleyl diamine is a liquid/paste witha
vapour pressure less than 0.0015 Pa at 20°C (value based on read-across
from shorter chain C12-14-diamine). Also the use of this
substance will not result in aerosols, particles or droplets of an
inhalable size, so exposure to humans via the inhalation route will be
unlikely to occur. Consequently, despite the irritant nature of the
substance, respiratory irritation is not expected.
Available data indicate corrosive
properties following exposures of 1 hour and longer. Following
exposures, the skin destruction is observed at examination the next day,
but not yet at the observation 1 hour after the exposure.Consequently,
GHS classification Corrosive Category 1B is appropriate, with hazard
statement H314: Causes severe skin burns and eye damage.
Due to corrosive properties
demonstrated in the dermal irritation/corrosion study with this
substance, testing in eyes is not justified. Under GHS with the hazard
phrase ‘H314 Causes severe skin burns and eye damage’ additional
classification for eyes is not necessary.
is no information is available following exposure via inhalation.
However, with a vapour pressure of less than 0.0015 Pa at 20°C,
potential for inhalation of vapours is limited.Also
the use of this substance will not result in aerosols, particles or
droplets of an inhalable size, so exposure to humans via the inhalation
route will be unlikely to occur.Consequently,
despite the irritant nature of the substance, respiratory irritation is
not expected, and classification STOT-SE Cat.3 for respiratory
irritation is not required.
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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