Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-01-03 to 1991-01-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Good laboratory practice guideline study (OECD).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

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
Details on test material:
- Name of test material (as cited in study report): Vinyllaurat
- Physical state: colourless liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 959837
- Stability under test conditions: stable

Test animals

Species:
rabbit
Strain:
Californian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Zimmermann GbR; Schweizer Hof Untergröningen; Germany
- Weight at study initiation: 3.2-3.3 kg
- Age: not specified in test report
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): 45-70 % rel. humidity
- Air changes (per hr): not given in report
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: shaved other side served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: patch held with an non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation was observed at any time in any animal.
Other effects:
No acute toxic effects could be detected.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritating to the skin of rabbits under the conditions used.
Executive summary:

Three male Californian rabbits were trated in an acute skin irritation study according to OECD guideline 404 with 0.5 ml of vinyl laurate. The substance was administered semiocclusively on a shaved area of the back side using nontoxic tape for 4 hours and then washed with water. A shaved but untreated skin area of the same animals saved as control. A 14 days observation period followed. No signs of irritating effects according to the guideline scoring sceme were seen at any time in any animal. No other signs of toxicity were found. The body weight gain was in the expected range for untreated animals of this type in this study.