Registration Dossier

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:
1986-02-18 to 1986-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study (EU & OECD) with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP compliance statement attached to full study report.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
- Identification: numbered earmarks
- Weight: 2.3 - 2.5 kg
- Age: approx. 3 - 5 months
- Housing: in air conditioned rooms in single cages
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting conditions: 12 hours daily
- Diet: Altromin 2123, ad libitum, hay: approx 15 g daily
- Water: deionised, chlorinated water from automatic dispensers, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
- Amount applied: 100 mg of test substance
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
1, 24, 48, 72 hrs
Number of animals or in vitro replicates:
3
Details on study design:
- Washing: 24 hrs after application of test substance. At all other examinations at which discharge was observed or cornea was examined.
- Washing with physiol. saline solution (37 °C)
- Cornea examined for possible damages using fluorescin-sodium solution (0.01 %) and under ultraviolett light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Irritant / corrosive response data:
1 hour to 24 hours p.a. all animals showed slight clear discharges. Conjunctivae were slightly to obviously swollen and crimsonred. The iris of all animals was reddish. One animal showed 24 hours p.a. scattered opacity in the cornea. 48 hrs only one animal had some clearly visible blood vessels in the eyes. 72 hrs p.a. all animals were clear of any signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU