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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrofurfuryl acrylate
EC Number:
219-268-7
EC Name:
Tetrahydrofurfuryl acrylate
Cas Number:
2399-48-6
Molecular formula:
C8H12O3
IUPAC Name:
tetrahydrofuran-2-ylmethyl acrylate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.8-3.1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
2 females and 1 male
Details on study design:
A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 ml per animal.
For observation, the eye were not rinsed.

OBSERVATIONS :
-viability : daily
-Body weight : pre-test, day 1 and at the termination of test
-Eye reaction: 1h, 24h, 48h and 72h after administration

The study was terminated 72 hours after administration of the test article.
All rabbits were killed at the end of the observation period.
No macroscopic organ examination was performed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Individual scores : 2-2-2
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.8
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Individual scores: 1.0-0.7-0.7
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Individual scores: 3-3-3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
2.8
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Individual scores : 2.7 - 3.0 -2.7
Irritant / corrosive response data:
The test article showed a primary irritation score of 8.1 when applied to the rabbit eye mucosa.
In the area of application, no discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed.
Opaqueness of the cornea was observed in any animal during the observation period.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
The body weight fain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on these results, Tetrahydrofurfuryl acrylate is considered to be severely irritating to the eyes of rabbit.
Executive summary:

The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of Tetrahydrofurfuryl acrylate are placed in the conjunctival sac of rabbit eyes.

Under the conditions of this experiment, Tetrahydrofurfuryl acrylate was found to cause a primary irritation score of 8.1 when applied to the rabbit eye mucosa.

The eye effects are not reversible. In the area of application, no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. Opaqueness of the cornea was observed in any animal during the observation period.

Based on these results, Tetrahydrofurfuryl acrylate is considered to be severely irritating to the eyes of rabbit.