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EC number: 204-101-2
CAS number: 115-70-8
Skin: not irritatingEye: corrosive
The liquid material applied easily on the skin. There was no erythema or
edema in any of the rabbits at 4, 24, and 48 hours. The treated skin
sites were normal and there was no tissue destruction.
The primary skin irritation test with AEPD was conducted on a group of
six albino rabbits. The skin from the back area of each rabbit was
clipped free of hair. The skin on the left side of the middorsal line
was left intact while the skin on the right side was abraded by making
minor epidermal incisions in a tic-tac-toe pattern with a blunt
hypodermic needle. The abrasions were minor incisions through the
stratum corneum, but not deep enough to disturb the derma or produce
bleeding. A 0.5 ml of P-1050, as supplied, was applied to each site and
covered with a gauze pad. The entire trunk was then wrapped with a
rubberized impervious cloth and a flexible wire screen held in place by
tape. After 24 h exposure, the bindings and patches were removed and the
treated sites were gently cleaned. The skin reactions were scored
immediately (24 h) and at the end of 72 h (48 h after the first scoring).
AEPD produced slight erythema and moderate to severe edema on all the
intact skin sites. The abraded skin sites showed severe edema and
necrosis. The average skin irritation score for the six rabbits was 4.6.
Since the material produced skin irritation, the animals were held for
further observation. All the treated intact skin sites were normal by
day 7, but the abraded skin sites showed eschar formation by day 21. The
average body weight gains of the treated animals were normal.
2-Amino-2-ethyl-1,3-propanediol or AEPD (P-1050) was tested in rabbits
to determine the eye irritation potential of the product. At 24 h, all
the animals’ corneas showed lesions and the eyes were severely
irritated. The eyes of the unwashed group of animals never recovered and
by day 14 were completely keratitised, and the animals were sacrificed.
The organs in all the animals were normal. The eyes of the washed group
of animals showed improvement by day 14 and were completely normal by
day 21. One of the rabbits in the unwashed group died on day 8 of the
test, and the post mortem examination showed that the animal was
suffering from severe diarrhea; the death was not related to the
In conclusion, undiluted AEPD was found to be severly irritating to
eyes. The unwashed eyes were permenently damaged by day 14. Washing the
material from the eye prevented irreversible damage (eyes normal at day
21), however the material was still severly irritating. The substance
needs to be classified as Category 2a (H319, severe eye irritation)
under the CLP/GHS Regulation (EC) No 1272/2008.
Several skin irritation studies with 2 -amino-2 -ethyl-1,3-propanediol
(AEPD) are available. AEPD is a highly alkaline substance; the pH of a
1% solution is 11.18 and of the 100% substance 11.78. In a reliable
study performed by Parekh (1982d) on rabbits, 0.5 mL of the test
substance was applied to shaved skin and covered with an occlusive
dressing for 24 hours. The test substance caused slight erythema and
moderate to severe oedema on all the exposed skin sites within 24 hours.
The effects were fully reversible within 72 hours in 5/6 animals and
within 7 days in all animals tested. Under the conditions of this study
(24 h exposure) the test substance showed a skin irritating potential.
Parekh performed an additional, reliable study (1982c) to assess the
specific skin corrosion potential of the test substance in rabbits. The
skin on the back of the animals was shaved and 0.5 mL of the test
substance applied and covered with an occlusive dressing for 4 hours.
The skin was then cleaned and examined. No erythema or oedema was
observed in any of the animals 24 and 48 hours after exposure ended.
Several other studies are also available. Sausaman (1975) reported that
the test substance had a slight irritating effect in rabbits, with an
overall irritation score of 1.37. In a study by Power (1974) the test
substance is reported to be non-corrosive to the skin of rabbits. Machle
(1941) assessed the potential skin irritating effect of AEPD in rabbits.
A sample was applied to the shaved skin of a rabbit in 2 doses, 30
minutes apart, with an exposure time of 30 to 60 minutes. The rabbit was
treated daily for 10 days. No skin irritating effects were observed
during the study period. Taking all the available data into account,
AEPD is not considered to be skin-irritating.
In a reliable study 0.1 mL AEPD was instilled into the eye of rabbits,
after which the eye was either rinsed after 20 -30 seconds or not rinsed
at all (Parekh, 1982). 24 hours after exposure, the corneas of the
exposed eyes of all animals showed lesions and were severely irritated.
Severe conjunctivae and chemosis were observed until 72 hours after
exposure. The effects on the rinsed eyes were completely reversed by day
21, while the eyes that were not rinsed were completely keratinized by
In the second study, Sausaman (1974) reported that the test substance
was corrosive to the rabbit eye, citing a maximum mean total score of
73.8. Taking the available data into account, AEPD is considered to have
a corrosive effect on the eye.
Effects on eye irritation: corrosive
The available data on skin irritation of the test substance do not meet
the criteria for classification according to Regulation (EC) 1272/2008
or Directive 67/548/EEC, and are therefore conclusive but not sufficient
The available data on eye irritation of the test substance meet the
criteria for classification as Category 1 (H318) according to Regulation
(EC) 1272/2008 and as Xi, R41 according to Directive 67/548/EEC.
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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