Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan 26 to Feb 18, 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
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
84/449/EEC Part B Acute Toxicity
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
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 7 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
- Site: right flank
- Evaluation (hrs after challenge):24 and 48 hr after challenge.

Body weights were measuredc twice during the pretreatment period, on the day of the first and second induction, on the day of the challenge and on the final day of the observations
Challenge controls:
10 animals with 0.2% Hydroxypropyl methylcellulose for the 1st induction, petrolatum for the 2nd induction. Challenge: 55% Abbott-164220 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)

Results
Reading:
other: Challenge
Hours after challenge:
48
Group:
test group
Dose level:
55% in petrolatum
No. with + reactions:
0
Total no. in group:
19
Clinical observations:
No signs of irritation
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Abbott-164220 did not induce delayed contact hypersensitivity in guinea pigs in this study. Criteria used for interpretation of results: EU
Conclusions:
Abbott-164220 did not induce delayed contact hypersensitivity in guinea pigs in this study.