Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Sept - 02 Oct, 1997
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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
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: Charles River Labs, Montreal, Canada
- Age at study initiation: 10- 15weeks
- Weight at study initiation: 2.2 - 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: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 65 - 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:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
4hr
Observation period:
30mins, 24hr, 48hr and 72hr after dressing removed
Number of animals:
6
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.

Results and discussion

In vivo

Resultsopen allclose all
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Abbott-87440 was found to be non-irritating to the skin of rabbits following topical appplication in this study.

Any other information on results incl. tables

No signs of dermal irritation were noted at the site of exposure in any of the 6 rabbits at any observation period in this study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Abbott-87440 was found to be non-irritating to the skin of rabbits following topical appplication in this study.

Executive summary:

No signs of dermal irritation were noted at the site of exposure in ay of the 6 rabbits at any observation period.