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EC number: 406-420-4
CAS number: 69430-40-6
PRIMARY IRRITATION EXPERIMENTS
No signs of systemic toxicity were observed during the primary
irritation experiments. However body weight loss was noted in one of the
five animals. The choice of propylene glycol as vehicle in this test was
based on the following: - the test substance dissolved well in propylene
glycol at the concentrations used. - the test substance is stable in
In accordance with Magnusson and Kligman (1969), based on the findings
in the primary irritation experiments and from the test substance
concentrations tested in the first inconclusive Maximization Test, the
following concentrations were selected for the induction and challenge
Intradermal induction: 50% (w/w) in propylene glycol
Challenge: a = 10% (w/w) in
b = 3% (w/w) in propylene propylene
c = 1% (w/w) in propylene glycol
d = propylene glycol
INDUCTION All experimental animals showed slight or moderate erythema
and slight oedema after the 48 hours occluded epidermal induction
All ten animals showed a skin reaction in response to the 10% test
substance concentration. These skin reactions were characterised by
redness, swelling and/or scaliness. No skin reactions were observed in
response to the 3% and 1% concentrations.
Fourteen, four and four animals showed a skin reaction in response to
the l0%, 3% and 1% test substance concentrations. These reactions were
characterised by redness, swelling and/or scaliness (see table 3,
Appendix 1). Taking into account the intensity of the responses and
comparing these with the reactions seen in the control animals, four of
the animals showed a positive skin reaction in response to the 3% and 1%
concentrations. No animals showed a positive skin reaction in response
to the 10% concentration.
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the
study. No mortality occurred during the study.
A marked difference in the average body weight gain of experimental and
control animals was noted.
The study was entitled "Assessment for Contact Hypersensitivity to
DC-5067 in the Albino Guinea Pig (Maximization Test)". The purpose of
the study was to obtain information on the potential of DC-5067 to
induce delayed contact hypersensitivity (skin sensitization) in the
guinea pig after intradermal and epidermal exposures. This study was
carried out in accordance with the OECD Guideline Number 406 and in
accordance with the method described by Magnusson and Klingman. The
experimental animals were intradermally injected with a 2.5%
concentration and epidermally exposed with a 50% concentration. Two
weeks after the epidermal application all animals were challenged with
the following test substance concentrations (10%, 3% and 1%) and the
vehicle (propylene glycol). The epidermal exposure of DC-5067 in the
introduction phase resulted in slight to moderate skin irritation. The
epidermal exposure of DC-5067 in the challenge phase resulted in four
positive sensitization reactions in response to the 3% and 1% test
substance concentrations. Under the conditions used in this study,
DC-5067 resulted in a sensitization rate of 20%. Applying the rating of
allergenicity described by Klingman, A. M. (-1966) on the results
obtained in this test, DC-5067 is considered to have mild sensitizing
properties. Applying the EEC criteria-for classification, DC-5067 need
not be labeled as a skin sensitizer.
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