Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000-2-3 to 2000-6-8
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
OPA-ACETAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Other effects:
- Lesions and clinical observations: No other than ocular lesions were noted. All lesions were reversible within 48 hours p.a.
- Ophthalmoscopic findings: Cornea and Irises: Not affected
Conjunctivae, redness: In all animals, some injected blood vessels were observed from 1 h onwards until a maximum of 24 hours p.a.
Conjunctivae, chemosis: Very slight swelling was seen in all animals 1 h p.a.

Applicant's summary and conclusion

Executive summary:

"OPA- ACETAL" is only slightly irritating to the eyes. According to the Directive 93/21/EEC, "OPA-ACETAL" is not regarded as irritating to the eyes.