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: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethylenglykoldivinylether, Substance number 96/283
- Analytical purity: ABOUT 98.4 % (GO)
- Physical state: LIQUID, ACHROMATIC, CLEAR
- Lot/batch No.: 3401/95-09
- Stability under test conditions: The stability of the test substance in olive oil DAB 10 for a time period of 4 hours was confirmd by analysis.
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH, BIBERACH, Germany
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: male: 3.69 kg; females: 3.84 and 4.0 kg
- Housing: single
- Diet: Kliba-Labordiaet 341, Klingenthalmühle AG Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: tap water, about 250 mL per animal per day.
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the dorsal of the trunk of the animals at least 24 hours before the test.
Vehicle:
not specified
Controls:
other: untreated skin sites of the same animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): unchanged liquid test substance


Duration of treatment / exposure:
4 hours
Observation period:
72 hours, Readings after 1, 24, 48 and 72 hour(s) and after removel of the patch
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: The test patch (2.5 cm x 2.5 cm)
- Type of wrap if used: The test patch was moistened with a dose of 0.5 mL of the unchanged liquid test substance and secured in position with a
semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol (R) (= Polyethylenglycol DAB, BASF AG) and Lutrol (R) / Water (1:1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within:
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects between 24 and 72 hrs
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
No other effects were observed.

Any other information on results incl. tables

The skin findings were reversible in all animals within 48 hours after removal of the patches; thus, the study was terminated after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the test conditions chosen Triethylenglycoldivinylether does not give indication of an irritant property to the skin.
Executive summary:

The potential of Triethylenglycoldivinylether to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 whiterabbits for 4 hours under semi-occlusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.2 for erythema and 0.0 for edema. The skin findings were reversible in all animals within 48 hours after removal of the patches; thus the study was terminated after 72 hours. Under the test conditions chosen and considering the described findings Triethylenglycoldivinylether does not give indication of an irritant property to the skin.