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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 September 1984 and 28 September 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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl vinylphosphonate
EC Number:
225-076-4
EC Name:
Dimethyl vinylphosphonate
Cas Number:
4645-32-3
Molecular formula:
C4H9O3P
IUPAC Name:
Dimethyl ethenylphosphonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: individually
- Diet: ad libitum (Altromin 2123)
- Water: ad libitum (deionised, chlorated water)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Yes (physiological saline solution)
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
- 1 hour after application: Animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally.
- 24 hours after application: Two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.
- 72 hours after application: All animals were symptom-free.
Other effects:
- Ophthalmoscopic findings: none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not considered to be irritanting to rabbits' eye according to OECD TG 405.
Executive summary:

The acute eye irritation study of the test item was performed in three New Zealand White rabbits according to OECD 405. The irritation effect of the test item was evaluated according to the Draize method. A single dose of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were washed out 24 hours after application. The eyes were examined at 1, 24, 48, and 72 hours after the application.

One hour after application animal 3 showed strong chemosis (score 3). In one animal, the vessels of the conjunctivae were clearly injected, in the second animal there was a diffuse, crimson redness. Hyperemia of the iris appeared, as well as slight corneal opacity occured occasionally. 24 hours after application two animals were symptom-free. One animal showed marked swelling, as well as diffuse fleshy redness at the conjunctivae. Furthermore, a hyperemia of the iris and a slight corneal opacity was observed. The symptoms were accompanied by whitish discharge.

All animals were symptom-free 72 hours after application.

For animal 1 and 2, the mean scores (considering readings at 24, 48 and 72 hours after test item application) were 0 for cornea opacity, 0 for iris, 0 for conjunctivae redness and 0 for chemosis. For animal 3, the mean scores were 0.7 for corneal opacity, 0.7 for iris, 1.3 for conjunctivae redness and 1.0 for chemosis. Therefore, the test item is not considered to be irritating to rabbits’ eye.