Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 25 July 1995 to 31 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
OECD guideline not specified.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test compound/batch: SR 48941 2/batch 5SNP501.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Three New Zealand White rabbits, two males and one female, identified by vendor attached plastic ear tag or implanted microship and study animal identification number written with indelible ink pen inside the right ear and housed one per cage.
- Source: Hazleton Research Products, Inc
- Age at study initiation: three to six months old
- Weight at study initiation: rabbits were weighed on Day-1 and body weights ranged from 3.0 to 3.5 kg.
- Housing: the rabbits were caged in an environmentally controlled room
- Diet : 125 grams/rabbit/day of Purina Certified High Fiber Rabbit Chow No. 5325 Lot 17 May 95 2A and 15 June 95 1B
- Water (e.g. ad libitum): municipal water (via an automatic watering system)

ENVIRONMENTAL CONDITIONS
- Temperature: 64-68°F
- Relative Humidity: 40-60 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycles.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: No control article was used; untreated sited served as controls.
Amount / concentration applied:
500 mg of solid compound
Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3, two males and one female
Details on study design:
On Day 1 of the study, 500 mg of solid compound was applied to a 6 cm² area on the right side of sheared backs, the left side serving as control. The areas were covered with gauze, the backs wrapped with a semi-occlusive dressing, and Elizabethan collars donned for approximately 4 hrs.

OBSERVED EFFECTS AND MORTALITY
The rabbits were observed at least once daily throughout the study, until termination on Day 7, for changes in appearance and behavior and mortality.

BODY WEIGHTS
The rabbits were weighed on Day -1.

OBSERVATION AND SCORING
Control and treated sites were assessed for erythema and edema 1 hr (Day 1), then 24 (Day 2), 48 (Day 3) and 72 (Day 4) hrs after dressing removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hrs
Score:
0
Max. score:
0
Irritant / corrosive response data:
SR 48941 (batch 5SNP501) was without response in all animals. Mean values were not calculated due to lack of observable cutaneous irritation.
Other effects:
No clinical signs of toxicity were observed in any rabbit and no deaths occurred during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, SR 48941 (batch 5SNP501) is not a reportable skin irritant.