Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-01-16 until 1991-01-24
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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
Californian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Zimmermann GbR; Schweizer Hof Untergröningen; Germany
- Weight at study initiation: 2.5-3.0 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, after 24 hours

SCORING SYSTEM: as laid down in OECD Guideline 405


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24 + 48 + 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritating effect was noted at any time in any of the animals.
Other effects:
none stated

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has not to be classified as irritant according to the EU regulations.
Executive summary:

Three male Californian rabbits were trated in an acute eye irritation study according to OECD guideline 405 with 0.1 ml of vinyl laurate. The untreated eye of the same animals saved as control. 24 hours after treatment the eyes were washed. A three 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.