Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-06-24 to 1999-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.41 - 2.70 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area : 3000 cm2. No bedding in the cages; wood shavings in the waste trays.
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: For at least 1 week .

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully air-conditioned rooms.
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6 .00 a.m. - 6 .00 p.m./6 .00 p.m . - 6 .00 a .m.)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL (unchanged)
Duration of treatment / exposure:
single dose for 24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
1 female
2 males
Details on study design:
- Application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid. Both eyes of the animal(s) were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
- Readings: 1 h, 24 h, 48 h, 72 h and 7 d after application.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.

REMOVAL OF TEST SUBSTANCE
- Washing: the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
- Time after start of exposure: 24 hours

SCORING SYSTEM: as specified in OECD 405 (1987) and EEC directive 92/69, L 383A, B.5 (1992)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
One of three animals showed small retractions in the eyelid (24 h - 72 h). Loss of corneal tissue was observed for two of three animals (48 h - 72 h), aswell as discharge of blood and suppuration occured for one animal after 48 h. All symptons were reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU