Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 27 to Feb 19, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
92/69/EEC Part B
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study carried out in 1998

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl:(HA)BR Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc, Portage, Michigan
- Age at study initiation: 2 - 3 weeks
- Weight at study initiation: 200 - 250gram
- Housing: Individual Stainless Steel ventilated cages
- Diet: Certified Guinea Pig Chow®
- Water: ad libitum
- Acclimation period: 5 days followed by an 8 day pretreatment period.

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72
- Humidity (%): Ambient
- Photoperiod (hrs dark / hrs light): 12hr daily light cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 0.2% HPMC for 1st induction: Petrolatum for 2nd induction and challenges.
Concentration / amount:
Concentration of test material at First Induction (Intradermal injection): 5% in 0.2% HPMC.
Concentration of test material at Second Induction (topical application): 55% in petrolatum
Concentration of test material used for challenge (topical applications): 55% in petrolatum
Challengeopen allclose all
Route:
other: Topically
Vehicle:
other: 0.2% HPMC for 1st induction: Petrolatum for 2nd induction and challenges.
Concentration / amount:
Concentration of test material at First Induction (Intradermal injection): 5% in 0.2% HPMC.
Concentration of test material at Second Induction (topical application): 55% in petrolatum
Concentration of test material used for challenge (topical applications): 55% in petrolatum
No. of animals per dose:
10 animals assigned to the negative control group.
20 animals assigned to treatment group.
Details on study design:
MAIN STUDY

An approximate 40 x 60mm area of dorsal skin on the scapular region was clipped free of hair prior to treatment

A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and topical
- Exposure period: 7 days for first induction and 14 days for second induction.
- Observations: 24hrs after the intradermal injections and once daily for 5 days. 24 and 48hrs after second induction.
- 0.05ml injection vol.
- Site for 2nd induction was pre-treared by massaging 0.3ml of 10% sodium dodecyl sulphate in water into the skin of animals in both groups on the day prior to topical inductionto illicit an inflammatory reaction.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: Day 21
- Exposure period: 24hr occlusive bandage
- Test groups:
- Site: right flank
- Evaluation (hrs after challenge):24 and 48 hr after challenge.
Challenge controls:
10 animals with 0.2% Hydroxypropyl methylcellulose for the 1st induction, petrolatum for the 2nd induction. Challenge: 55% Abbott-172245 in petrolatum.
Positive control substance(s):
not required
Remarks:
Sensitivity tested periodically with α-hexylcinnamaldehyde

Results and discussion

Positive control results:
n/a

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 1st induction
Hours after challenge:
24
Group:
test group
Dose level:
5% in 0.2% HPMC
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
slightly patchy erythema
Remarks on result:
other: Reading: other: 1st induction. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in 0.2% HPMC. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: slightly patchy erythema.
Reading:
other: 2nd induction
Hours after challenge:
24
Group:
test group
Dose level:
55% in petrolatum
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
slight to patchy erythema
Remarks on result:
other: Reading: other: 2nd induction. . Hours after challenge: 24.0. Group: test group. Dose level: 55% in petrolatum. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: slight to patchy erythema.
Reading:
other: Challenge
Hours after challenge:
48
Group:
test group
Dose level:
55% in petrolatum
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of irritation
Remarks on result:
other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 55% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Abbott-172245 did not induce delayed contact hypersensitivity in guinea pigs in this study. Criteria used for interpretation of results: EU
Conclusions:
Abbott-172245 did not induce delayed contact hypersensitivity in guinea pigs in this study.