Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
and Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: Charles River Laboratories France
- Age at study initiation: 1-2 months
- Weight at study initiation: males: 351 ± 11 g; females 349 ± 16 g
- Housing: individually in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm) equipped with a polypropylene bottle
- Diet (e.g. ad libitum): ad libitum, 106 pelleted diet (SAFE, Villemoisson, Epinoy-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water filtered
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
0.1 (w/v) % (test item in corn oil) for intradermal induction
30 (w/v) % (in acetone) for dermal induction and challenge treatment
Challengeopen allclose all
Route:
other: topical, occlusive
Vehicle:
corn oil
Concentration / amount:
0.1 (w/v) % (test item in corn oil) for intradermal induction
30 (w/v) % (in acetone) for dermal induction and challenge treatment
No. of animals per dose:
2 males and 2 females for the preliminary test
10 males and 10 females for the main test and 5 males and 5 females as controls
Details on study design:
RANGE FINDING TESTS:
Intradermal: 0.1 ml doses of the test item 0.1 % were injected into the interscapular region and local reactions were evaluated
approx. 24, 48 hours and 6 days after the injections.
Cutaneous route: a filter paper (~8 cm2) was fully loaded with a dosage form preparation and was then applied to the clipped area of the skin.
(It was held in place by means of an occlusive dressing for 48 hours.)
Cutaneous reactions were evaluated 24 and 48 hours after removal of the dressings.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal route: day 1 - 6 inj. 3 inj. of 0.1 ml into both side ie. 3 pairs of sites: Antenior (FCA alone), Middle (test item) Posterior (FCA+Test item)
cutaneous route: one (Day 8).
- Exposure period: 48 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Duration: intradermal: 6 days, cutaneous: 14 days


B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
no
Remarks:
mercaptobenzothiazole (laboratory historical data)

Results and discussion

Positive control results:
--

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
discrete erythema (grade 1) together with dryness of the skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30 %
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
discrete erythema (grade 1) together with dryness of the skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: both control and test group
Dose level:
30 %
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
discrete erythema (grade 1) together with dryness of the skin persisted
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: both control and test group. Dose level: 30 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: discrete erythema (grade 1) together with dryness of the skin persisted.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No delayed contact hypersensitivity in guinea pigs.
Not classified as sensitizing to the skin.