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EC number: 215-089-3
CAS number: 1300-71-6
Intradermal induction, moderate and
copnfluent erythema and swelling were observed at the injection sites of
all control group animals and all test group animals at which only
Freund's adjuvant in NaCl was applied. Necrotic changes and swelling
were observed in the other sites (lutrol E 400 DAB and 50% Lutrol with
FCA / 0.9% NaCl(aq)).
Injections with 0.5% test substance in
Lutrol E 400 DAB also caused swelling and necrotic skin changes.
Moderate and confluent erythema and swelling were observed at the
injection sites of all test group animals which were applied with a 0.5%
test test substance preparation in FCA/0.9% NaCl (aq).
Percutaneous induction (1 week later):
Controls treated with Lutrol E 400 (no reaction). Induction with 2,4
xylenol (25% in Lutrol E 400 DAB) gave rise to swelling and necrotic
1st challenge (14 days later): No findings
in all control animals at 24 or 48hrs.
Test animals 24hrs: 1/20 intense erythema
and swelling; 8/20 moderate and confluent erythema; 2/20 discrete or
Test animals 48hrs: 4/20 moderate and
confluent erythema; 3/20 discrete or patchy erythema.2/20 dscrete or
patchy erythema as well as scaling
2nd challenge (1 week later): No findings in
all control animals at 24 or 48hrs.
Test animals 24hrs: 4/20 moderate and
confluent erythema; 3/20 discrete or patchy erythema.
Test animals 48hrs: 1/20 moderate and
confluent erythema; 5/20 discrete or patchy erythema
Challenge and rechallenge results presented
Table 1: 1st Control group - intradermal
Form of application
A. Freund’s adjuvant / 0.9% NaCl (aq) 1:1
B Lutrol E 400 DAB
C 50% preparation of Lutrol E 400 DAB with Freund’s adjuvant / 0.9% NaCl (aq) 1:1
2: 2nd Control group - intradermal indcution:
3: Test group - intradermal induction:
B Test substance 0.5% in Lutrol E 400 DAB
C Test substance 0.5% in Freund’s adjuvant / 0.9% NaCl (aq) 1:1
= Moderate and confluent erythema
= necrotic skin changes
4: 1st Control group - percutaneous induction
Form of application: Lutrol E 400 DAB
5: 2nd Control group - percutaneous induction
6: Test group - percutaneous induction
Form of application: Test substance 25% in Lutrol E 400 DAB
In a dermal
sensitization study, guinea pigs (20/sex) received intradermal
injections of 0.5% 2,4 xylenol (administered in Lutrol E 400 DAB and
Freund’s Complete Adjuvant (FCA)) / 0.9% NaCl (1:1)). The
treatment regime involved induction of sensitization by intradermal
injection on day 1, induction of sensitization by topical administration
one week later (25% 2,4 xylenol in Lutrol E 400 DAB), challenge by
topical administration on day 21 (5% 2,4 xylenol in Lutrol E 400 DAB),
followed by a rechallenge on day 28 (5%
2,4 xylenol in Lutrol E 400 DAB).
intradermal induction, 0.5% 2,4 xylenol caused swelling and moderate
erythema. One week laterm percutaneous induction with 25% 2,4 xylenol in
Lutrol E 400 DAB resulted in swelling and necrotic changes. Following
challenge, 11/20 test animals test animals showed a positive allergic
reaction. Following rechallenge 8/20
test animals showed a positive allergic reaction.
The 5% 2,4 xylenol applied to control animals was tolerated and no skin
reactions were observed in the control groups.
2,4 xylenol showed a clear skin
sensitisation potential in this study.
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