Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Sept 1997 - 16 Mar 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:
1997
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
92/69/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc. Kalamazoo, Michigan
- Age at study initiation: 14weeks
- Weight at study initiation: 2.0 - 2.5kg
- Housing: Individual stainless steel ventilated hanging cages
- Diet: Rations of approx 100 - 130g/day Certified High Fibre Rabbit Chow
- Water: ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature: 68 - 70°F
- Humidity (%): Ambient
- Photoperiod (hrs dark / hrs light): 12 hr daily light cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Sterile water for Injection
Controls:
no
Amount / concentration applied:
0.5gram
Duration of treatment / exposure:
4hr
Observation period:
30mins, 24hr, 48hr and 72hr after dressing removed.
Observation period extended to 4, 7 and 10 days for two rabbits with adverse effects.
Number of animals:
5
Details on study design:
1 day prior to treatment, hair was clipped from the dorso-lumbar region of each rabbit, exposing an area of skin approx. 100 x 100mm.
The animals were not restrained during the exposure period.
Material applied to approx 6cm² area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 hrs
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 Days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Day 4
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: No sign of local dermal irritation
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: No sign of local dermal irritation
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Remarks on result:
other: No sign of local dermal irritation
Irritant / corrosive response data:
Abbott-164220 was found to be non-irritating to the skin of three rabbits and slightly irritating to the skin of two rabbits following 4 hours of exposure in this study.

Any other information on results incl. tables

No signs of local dermal irritation were noted at the site of exposure were noted in 3 of the 5 rabbits tested at any observation through and including the 72 hour observation following initial application. Slight erythema and edema were observed in each of the 2 remaining rabbits. Very slight erythema and edema were observed in these same rabbits by observation day 4. All signs of irritation were reversible by observation day 10.

Applicant's summary and conclusion

Conclusions:
Abbott-164220 was found to be non-irritating to the skin of 3 rabbits and slightly irritating to the skin of 2 rabbits following four hours of exposure in this study.