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EC number: 203-804-1
CAS number: 110-80-5
Results on preliminary experiment:
For the intracutane application the test substance concentrations 0.25,
0.5, and 1.0 % induced only hardly visible erythema. The higher
concentration (2.5, 5.0, 10 %) resulted in hardly visible erythema and
oedema. According to these results a substance preparation of 10 % test
substance in physiological saline was used for the intracutane induction
in the main experiment.
For the dermal application no administered test substance concentration
was irritating to the skin (evaluation 24 and 72 h after application.
Therefore the undiluted test substance was used for the dermal
application in the main experiment. As the undiluted substance was not
irritant, the animals skin was pretreated with sodium dodecylsulfate in
order to cause an irritation for the main experiment.
Details on preliminary intracutane application:
Animal 2 (24 hours post application)
Erythema and scab formation (E)
Oedema formation (O)
Details on preliminary dermal application:
Results on main experiment:
The weight gain during the study period was normal for the 19 testing
and 19 control animals. For the treated animals no toxic effects were
visible during the study period.
Intracutane induction (day 0):
One hour after the intracutane injection of Freund's Complete Adjuvant
(FCA, 50 % in physiological NaCl) all test and control animals showed
medium to heavy erythema and oedema. After 24 hours all animals showed
heavy erythema (deeply injured) and heavy oedema.
The injection of the test substance (10 % in physiological NaCl
solution) showed one hour after the application only hardly obvious
irritation in all animals. 24 hours after the application an evaluation
of these injection sites were no more possible because of the heavy skin
reactions at the FCA injection sites.
The injection sites of all control animals, which have only been treated
with the vehicle (physiological NaCl), showed after 1 hour and 24 hours
comparable weak reactions as in the testing animals treated with 10 % of
the test substance.
The mixed injection of test substance with FCA (1 + 1 dilution with
physiological NaCl) resulted in all test animals one hour and 24 hours
after the application heavy erythema with deep injuries (scab) and heavy
The combined injection of FCA and physiological NaCl resulted one hour
after the application in medium erythema and medium oedema in all
control animals. 24 hours after the application the results showed heavy
erythema with deep injuries (scab) and heavy oedema in all control
Dermal induction (day 7):
Pretreatment of the cropped skin with sodium dodecylsulfate resulted in
reddening and swelling of the skin of all testing and control animals.
Removal of the occlusively fixed patches (positioned at the injection
sites treated with FCA, 50 % in physiological NaCl) resulted in heavy
erythema with deep injuries in all animals (testing and control) 49 and
72 hours post application. The injection sites were partly bleeding or
covered with scab. Additionally heavy oedema were observed.
The injection sites treated with test substance (10 % in physiological
NaCl) and only with vehicle could not be evaluated individually 49 and
72 hours post application, because the whole application area was
irritated. Flakes of skin were visible at this area 72 hours post
The injection sites treated with 10 % of the test substance in FCA (1 +
1 dilution with physiological NaCl) showed in all animals 49 and 72
hours after the application heavy erythema with deep injuries (partly
bleeding), and heavy oedema.
The injection sites treated with FCA and physiological NaCl (1 + 1
dilution) in the control animals showed comparable results as observed
in the testing group 49 and 72 hours post application.
Challenge (day 21):
48 and 72 hours after the application the 19 testing animals as well as
the 10 animals from control group 1 showed no irritation of the skin at
the application site (no animals with erythema nor oedema). Because of
this result, a second challenge was not conducted.
The test substance 2 -ethoxyethanol showed no sensitising potential to
the skin of guinea pigs as the dermal reaction of the testing group
according to the challenge was equal (no irritation) to that of the
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