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EC number: 931-295-2
CAS number: -
Etherdiamine C13i/acetate was shown to cause
corrosive effects to rabbit skin following 3 minutes exposure. Necrotic
effects became visible 24 hour after exposure but were not yet present 1
hour after exposure.
Skin irritation scores:
* Examinations were performed at the
specified times after removal of the dressing.
n.a. = not assessable due to necrosis
produced by the test item.
† = no observation point (animal was killed
on test day 2)
Skin Irritation Scores - Mean Values
after 24, 48 and 72 Hours
Not applicable. Since one animal was killed
after the 24-hour observation point (female) and one
animal after the 48-hour observation point
(male), mean scores could not be assessed.
Skin Irritation Scores - Assessment
According to EC Classification Guidelines
3 min (91, M)
1h, 24h, 48h
4 hours (92, F)
Body weights (g):
skin irritation potential of Alkoxypropandiamineacetate and
alkoxypropandiamine was investigated according to OECD test guideline
No. 404 and Commission Regulation (EC) No. 440/2008, B.4. The test item
was applied by topical semi-occlusive application of 0.5 mL to the
intact left flank of two adult New Zealand White rabbits. The duration
of treatment was four hours (for one female, by mistake) or three
minutes (for one male). The scoring of skin reactions was performed 1
and 24 hours (female) or 1, 24 and 48 hours after removal of the
score could not be calculated across 3 relevant scoring times (24, 48
and 72 hours after patch removal, according to the guidelines) since the
animals were killed due to ethical reasons either on test day 2 (female)
or 3 (male).
application of Alkoxypropandiamineacetate and alkoxypropandiamine to the
skin resulted in severe erythema and oedema and depigmentation of the
treated skin (blanching) one hour after the 4-hour application period
(female). At the 24-hour observation point, the entire treated skin area
was necrotic and the animal was killed for ethical reasons. Then, the
application period was shortened to 3 minutes (male). Well-defined
erythema, slight oedema and blanching were noted one hour after removal
of the dressing. However, at the 24-hour observation point, the treated
skin area evolved a necrosis, which persisted until the 48-hour
observation point when this animal was also killed for ethical reasons.
For both animals teated, no clinical signs were recorded throughout the
test item induced irreversible damage to the skin.
upon the referred classification criteria (Regulation (EC) No 1272/2008
of the European Parliament and of the Council of 16 December 2008),
Alkoxypropandiamineacetate and alkoxypropandiamine is classified in
Category 1: “Corrosive” and further in Subcategory 1B.
Data is available from in vivo dermal
corrosion/irritation study in rabbits with Etherdiamine C13i, the
substance without acetate. This study indicated corrosive properties
already after 3 minutes exposure.
It is possible that with the change to
acetate salt its physico-chemical properties are changed that could
influence the direct corrosive properties, and further studies to
evaluate dermal irritation/corrosion by Etherdiamine C13i/acetate were
Etherdiamine C13i/acetate was
non-corrosive in the in vitro skin irritation test applying a
human skin construct model. However, this study model has shown not to
provide reliable results for various fatty nitrile derivatives by
largely underestimating corrosive/irritating properties for these
compounds. Consequently, this study has been disregarded for the
evaluation of Etherdiamine C13i/acetate for
dermal irritation and an in vivo study was initiated.
Two rabbits were exposed to samples of
0.5 mL of Etherdiamine C13i/acetate applied to intact, clipped skin
using a semi-occlusive dressing. The duration of treatment was four
hours (for one female, by mistake) or three minutes (for one male). The
scoring of skin reactions was performed 1 and 24 hours (female) or 1, 24
and 48 hours after removal of the dressing.
application of Etherdiamine C13i/acetate to the skin resulted in severe
erythema and oedema and depigmentation of the treated skin (blanching)
one hour after the 4-hour application period (female). At the 24-hour
observation point, the entire treated skin area was necrotic and the
animal was killed for ethical reasons. Then, the application period was
shortened to 3 minutes (male). Well-defined erythema, slight oedema and
blanching were noted one hour after removal of the dressing. However, at
the 24-hour observation point, the treated skin area evolved a necrosis,
which persisted until the 48-hour observation point when this animal was
also killed for ethical reasons.
it is concluded that the presence of acetate does not impact corrosive
properties of the etherdiamine.
With results of highly corrosive for skin,
similar results are expected for the eyes. Further testing for eye
irritation is therefore not indicated.
is no information is available following exposure via inhalation. Likelihood
of exposures via inhalation is low considering the high boiling point (>
300 °C) and low vapour pressure (0.005 Pa at 25°C). The substance is
classified as severe corrosive and acute toxicity testing should
normally not be conducted.
The in vivo dermal corrosion
study in rabbits, indicates that Etherdiamine C13i/acetate causes
corrosive effects of the skin following 3 minutes exposure, which
developed during the course of a day. Consequently, GHS classification
1B is appropriate, with hazard statement H314: Causes severe skin burns
and eye damage.
There is no information is available
following exposure via inhalation. Inhalation may cause respiratory
irritation due to the corrosive properties of the substance. However,
with a vapour pressure of 0.005 Pa at 25 °C, potential for inhalation of
vapours is limited.
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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