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EC number: 233-138-7
CAS number: 10043-27-3
SKIN EFFECTS AFTER THE INDUCTION
At the 24-hour examination after the
intradermal induction exposure to 0.1% (w/v) test item formulated in
saline, very slight (barely perceptible) erythema (Draize score: 1) were
observed in two animals. No oedema was observed in any animals.
At the 1-hour examination after the dermal
induction exposure to 100% (w/v) test item, very slight (barely
perceptible) erythema (Draize score: 1) were observed in five animals;
giving a mean of the scores of 0.5. No oedema was observed in any
animals examined at this time. At the 24-, 48- and 72-hour examinations
after the dermal induction exposure to 100% (w/v) test item, no erythema
was observed anymore in test animals and no oedema was observed.
At the 24-hour examination after the
intradermal induction exposure to saline, neither erythema nor oedema
was observed in control animals.
At all examinations (1, 24, 48 and 72 hours)
after the dermal induction exposure to saline, neither erythema nor
oedema was observed in control animals.
Table 1: Summary of the result after
the challenge exposure
Groups and animals
24 hours after removal
48 hours after removal
Control – Animal 1
Control – Animal 2
Control – Animal 3
Control – Animal 4
Control – Animal 5
Dosed – Animal 6
Dosed – Animal 7
Dosed – Animal 8
Dosed – Animal 9
Dosed – Animal 10
Dosed – Animal 11
Dosed – Animal 12
Dosed – Animal 13
Dosed – Animal 14
Dosed – Animal 15
Left side was treated with 25% (w/v) test item formulated in saline, **:
Right side was treated with saline only.
There were no notable differences between
the test animal group and the control group. On Day 25 prior to
euthanasia, control and test animals presented a mean body weight of
463.2 g and 471.5 g, respectively.
CLINICAL OBSERVATIONS AND MORTALITY
No signs of systemic or local toxicity were
observed in any animal. No mortality was observed during the study.
There were no overt signs of an adverse clinical response to treatment
with the test item during the course of the study.
A skin sensitisation study was performed in
the guinea pig according to the Magnusson and Kligman method, using a
maximisation method with Freund's Complete Adjuvant to evaluate the
sensitisation potential of test item (OECD Guideline No. 406) and in
compliance with GLP guidelines.
Based on the results of a preliminary test,
ten test animals were subjected to sensitisation procedures in a
two-stage process, named induction phase: i.e. an intradermal treatment
and a 48-hour topical application (dermal treatment under an occlusive
dressing). The test item was used at a concentration of 0.1% (w/v) in
saline for intradermal injections and at a concentration of 100% (w/v)
in saline for topical sensitisation treatment. Five control guinea pigs
were simultaneously exposed to vehicle only during the sensitisation
phase; saline being used for both intradermal and dermal treatments.
Two weeks after the last induction exposure,
a challenge dose at a concentration of 25% (w/v) test item formulated in
saline was administered on the left side of all animals for 24 hours.
The right side of the animals was treated with vehicle only (saline).
Challenge was performed by dermal application of the test item. Test and
control animals were treated in the same way. Skin reactions were
measured 24 and 48 hours after patch removal.
No signs of systemic toxicity were observed
in any animal. After the challenge exposure, no signs of contact
sensitisation were detected in guinea pigs previously exposed to the
test item during the induction phase of the experiment. In the control
and treated animals the mean of the scores was 0.00 according to the 24
and 48-hour results.
In conclusion, under the conditions of the
present assay the test item Terbium trinitrate was shown to have no
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