Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG
- Age at study initiation: 9-10 months
- Weight at study initiation: 2.3-2.54 kg
- Housing: individually in stainless steel cages with grating floor
- Diet: standard Diet ssniff K ("special diet for rabbits") approx. 120 g/day / animal
- Water: drinking water ad libitum
- Acclimation period: 1 day under test conditions before application of the product

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24.4
- Humidity (%): 30-50
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 1.6 ml demineralized water

VEHICLE
- Amount(s) applied: 1.6 ml
Duration of treatment / exposure:
4 hours
Observation period:
3 days post application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: applied on the shorn dorsal skin area between shoulder and sacrum (approx. 6.25 cm²)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, after the end of the exposition time remaining test material was gently washed of
- Time after start of exposure: 4 hrs


SCORING SYSTEM:
The evaluation of the cutaneos irritation effect at observation times 1, 24, 48 and 72 hours post application was expressed by an irritation index.
The arithmetical mean values of the individual grades obtained from the skin areas at observation times 1, 24, 48 and 72 hours were calculated - separately for erythema- /eschar and edema formation. The irritation index is represented by the sum of these two mean values.
A corresponding gradation was allocated to this index by the following scheme:

Index Ranges Gradation
0.0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderatly irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: average of 24h, 48h,72
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
not irritating