Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 October 1997 - 31 October 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 404 and EU Method B.4 (Acute Dermal irritation/Corrosion) without deviations and GLP practices.

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:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Epyrrol
- Substance type: pure active substance
- Physical state: Powder, off white in color
- Composition of test material, percentage of components: Main component= 75%, other= 18%, other= 7%
- Lot/batch No.: GL-1291 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Not indicated
- Storage condition of test material: Stable at 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 Neitherlands
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually housed in cages with perforated floors
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pelleted diameter 4mm, Hope Farms, Woerden, The Neitherlands), approximately 100 grams per day. Additionally, hay was provided once per week.
- Water (e.g. ad libitum): Free access to tap-water with decalcified water
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions.

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

IN-LIFE DATES: From: Not documented in the study report To: Not documented in the study report

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
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:
Up to 72 hours after application (Observations were made 1, 24, 48 and 72 hours after exposure)
Number of animals:
Three animals of either sex
Details on study design:
TEST SITE
- Area of exposure: Skin of one flank/animal
- % coverage: % not specified in the study report, although an area of 150 square centimeters (10X15 cm2) was used for the exposure site
- Type of wrap if used: Scotchpak-non-woven patch of 2X3 cm mounted on Micropore tapeand secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Irritant / corrosive response data:
No irritation was caused by 4 hours of exposure to the test substance. There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin was observed. No symptoms of systemic toxicity in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin irritation was caused by 4 hours exposure to 0.5 grams of Epyrrol.