Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Epyrron
- Physical state: Off white powder
- Composition of test material, percentage of components: Main component 55%; Other 22% and 18%
- Lot/batch No.: GV-1458 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: 6 weeks old
- Weight at study initiation: Less than 3.5 kg
- Housing: Individual cages with perforated floors
- Diet: 100 grams/day of standard laboratory rabbit diet (LKK-20 pellet Hope Farms, Woerden, The Netherlands)
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams

VEHICLE
- Amount(s) applied (volume or weight with unit): water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Dorsal - Flank area
- Coverage: 150 cm squared
- Type of wrap if used: Scotchpak-non-woven of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Moistened tissue with tap-water
- Time after start of exposure: 4 Hours

SCORING SYSTEM:
See free text section below.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 Hour
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 Hour
Score:
>= 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 Hours
Score:
>= 0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 Hours
Score:
>= 0
Max. score:
4
Irritant / corrosive response data:
No skin irritation or corrosion was reported on rabbits after the exposure to test substance for 4 hours through the duration of the test.
Other effects:
No staining of the treated skin area was observed during the test period.

No toxicological symptoms were observed in any of the rabbits exposed to test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results and according to EU criteria the test substance when administered to rabbits at a dosage of 0.5 grams shall not be considered an irritant or corrosive to skin.