Registration Dossier

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:
10 - 25 Sep 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 Apr 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Commission Directive No. 2004/73/EC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Constituent 1
Chemical structure
Reference substance name:
Vinyl benzoate
EC Number:
212-214-3
EC Name:
Vinyl benzoate
Cas Number:
769-78-8
Molecular formula:
C9H8O2
IUPAC Name:
vinyl benzoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended cages
- Diet: certified rabbit diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system; reading time points: 1, 24, 48 and 72 h

TOOL USED TO ASSESS SCORE: ophthalmoscope

OTHER OBSERVATIONS:
Body weight was measured on Day 0 and 3.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h (animal #1)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
No corneal opacity was noted during the study. Iridial inflammation was noted in one treated eye one hour after treatment. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival redness at the 24-hour observation. Minimal conjunctival redness persisted in one treated eye at the 48-hour observation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation. Minimal conjunctival chemosis was observed 1 hour after instillation and was reversible within 24 hours.
Other effects:
- Other observations: All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1. Results of eye irritation/corrosion study in rabbits.

Alteration

Animal No.

Time (h)

 

1

 

24

 

48

 

72

mean 24/48/72 h

reversible within

Cornea

1

0

0

0

0

0

n.a.

2

0

0

0

0

0

n.a.

3

0

0

0

0

0

n.a.

Iris

1

1

0

0

0

0

24 h

2

0

0

0

0

0

n.a.

3

0

0

0

0

0

n.a.

Conjunctivae Redness

1

2

1

0

0

0.33

48 h

2

2

1

0

0

0.33

48 h

3

2

1

1

0

0.67

72 h

Conjunctivae Chemosis

1

1

0

0

0

0

24 h

2

1

0

0

0

0

24 h

3

1

0

0

0

0

24 h

n.a. : not applicable

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to CLP Regulation (EC) No 1272/2008
Conclusions:
Vinyl benzoate was tested for eye irritation in 3 rabbits according to the OECD TG 405. With respect to the findings reported at reading time points 24, 48 and 72 h for the 3 animals, the resulting mean Draize scores for corneal opacity and iritis were < 1 and for conjunctival redness and oedema < 2, respectively; thus no classification according the CLP Regulation is warranted and the compound is considered not to be an eye irritant according to the CLP criteria.