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EC number: 619-437-9
CAS number: 99474-22-3
RANGE FINDING STUDY
- Administration by intradermal route: the maximal tested concentration
was 1% in dimethylacetamide/acetone/ethanol (40/30/30). This
concentration caused irritation 24 h post dosing and then necrosis 48 h
post dosing. This concentration was chosen for the main test.
- Administration by topical route: 24 h after the removal of dressing,
both concentrations (10% in dimethylacetamide/acetone/ethanol (40/30/30)
and undiluted) caused no skin irritation, with a brown coloration of the
skin by the test material. Based on these results, the concentration
chosen for both the induction and challenge phases was 100% (undiluted
- Clinical examinations: One female of the treated group had a slight
decreased spontaneous activity and a decreased body weight during the
second week of observation. One male of the control group had a slight
decreased spontaneous activity, tremors and piloerection at Day 22 that
preceded the death of the animal by Day 23. One male of the treated
group was sacrified at Day 8 because of severe pre-death clinical signs
(hypokinesia, thinness, cold to the touch and dehydration). One female
of the treated group was found dead on Day 22 without apparent clinical
sign. As such spontaneous mortality is sometimes observed in this
species, it was not attributed to treatment with the test material.
- Body weight: body weight gain of 95% of the treated animals was
similar to that of controls (detailed results are presented in the study
report). An important weight loss was observed at Day 8 for the male
that was sacrified.
- Induction phase reactions: signs of skin irritation were recorded on
Day 10 after patch removal at the intradermal injection sites of animals
of the control group. Evaluation of the skin reactions of animals of the
treated group was not possible due to the black coloration of the skin
by the test material.
- Challenge phase reactions: No cutaneous reactions were observed for
the animals of the control group 48 and 72 h after dosing. In the
treated group, a discrete erythema (grade 1) was noted in 10/18 animals
the 48 h post challenge. 72 h post dosing, the discrete erythema (grade
1) only persisted in 3 animals. No edema or other cutaneous reactions
- Macroscopic findings: no findings after macroscopic examination of the
main organs of animals found dead or sacrified during the study.
This non-GLP study was performed to assess the potential of the test
material to induce and elicit delayed dermal sensitization according to
the guinea pig maximization test of Magnusson and Kligman described in
Magnusson B and Kligman AM., 1969.
Material and methods
Concentrations of the test material used in the main study were
determined by performing a range finding study. The selected
concentrations were: 1% in dimethylacetamide/acetone/ethanol (40/30/30)
for the intradermal injection and undiluted test material for the
induction and the challenge topical applications (necrotizing dose and
highest non irritant dose respectively).
The main study was undertaken using 30 male and female guinea pigs (20
in the test group and 10 in the control group). Test animals were
intradermally injected with FCA at 50% (v/v) in 0.9% NaCl (anterior
sites), the test material at 1% in
dimethylacetamide/acetone/ethanol (40/30/30) (middle sites), and the
test material suspended in the vehicle at 1% in FCA at 50% (v/v) in 0.9%
NaCl (posterior sites). One week later, animals were treated by topical
application of Sodium Lauryl Sulfate at 10% (w/w) in petrolatum in order
to induce a local irritation, and then boosted by topical application of
the undiluted test material under an occlusive dressing for 48h. Control
animals were treated in the same manner but using the vehicle praffin
oil instead of the test material. Two weeks after the second induction
stage, animals of the treated group were challenged by topical
application-under occlusive dressing for 24h- of both the vehicle and
the undiluted test material, while animals of the control group were
topical application-under occlusive dressing for 24h- of the undiluted
test material only. Skin reactions were evaluated 24 and 48 h after
removal of the dressing.
No systemic clinical signs and no deaths related to treatment were noted
during the study. The body weight gain of 95% of the animals of the
treated group was comprabale to that of the control group.
No well-defined macroscopic cutaneous reactions were observed after the
challenge application. The discrete erythema observed in 10/18 animals
of the treated group 48 h after dosing (reversing at 72h post dosing in
7of the 10 reacting animals) was considered as a slight primary skin
Under the experimental conditions of this study, the test material did
not elicit a skin sensitisation response in the guinea pig.
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