Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 August to 5 November 1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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
Test material form:
other: Solid
Details on test material:
- Name of test material (as cited in study report): Pymordiol
- Physical state: Cream white solid
- Purity of test material: 96 wt%
- Lot/batch No.: DGM096K1A
- Expiration date of the lot/batch: 1 January 2001
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, Someren, the Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually in cages with perforated floors.
- Diet: Approximately 100 g per day of standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water (e.g. ad libitum): Free-access to tap water.
- Acclimation period: 5 days

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

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 of single sex
Details on study design:
TEST SITE
- Area of exposure: Dorsal flank
- % coverage: 150 square centimetres
- Type of wrap if used: Metalline patch of 2x3 cm. 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): Water
- Time after start of exposure: 4 hours

SCORING SYSTEM: See table below

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
No evidence of irritation after 4 hours of exposure to test substance was reported.

See tables No. 1 & 2 below for details on individual animals and animal means.
Other effects:
No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual Skin Irritation Scores

Animal No.  494 496 518
Time after exposure (hours) Erythema Oedema Erythema Oedema Erythema Oedema
1 0 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0

Table 2: Mean Values of Skin Irritation Scores (24, 48 and 72 h after exposure):

Animal No. Mean 24-72 hours
Erythema Oedema
494 0 0
496 0 0
518 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the current test conditions test substance is not considered to be irritating to the skin.