Registration Dossier

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:
1998-02-03 - 1998-04-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on 24th Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

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:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA (on 01/20/98)
- Age at study initiation: Animals were born the weeks 11/09 through 11/23/97, Experimental Start Date: 02/09/98
- Weight at study initiation: 2.2 – 2.3 kg
- Housing: 1 animal/sex/cage in suspended wire cages, Bedding was changed three times/week
- Diet: Fresh Purina Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least five days
- Approximately 24 hours prior to study start, both eyes of each animal were examined

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light
- Animal room was temperature controlled, kept clean and vermin free

IN-LIFE DATES: From: 1998-02-09 To: 1998-02-12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as a control.
Amount / concentration applied:
33 mg test item
Duration of treatment / exposure:
Up to the end of the observation period, no removal after 24 hours.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 female rabbits
Details on study design:
APPLICATION
- Test article (0.1 mL equivalent [33 mg]) was placed by syringe-type applicator into the conjunctival sac. After instillation, the lids were held together for approximately one second. One eye of each rabbit was dosed.

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM
- according to the numerical Draize technique

TOOL USED TO ASSESS SCORE
- Sodium fluorescein

OTHER OBSERVATIONS
- Body weights were recorded pretest
- General health status of the animals was monitored at each observation time

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Corneal opacity and iritis, noted in 1/6 eyes, cleared by 48 hours. Conjunctival irritation, noted in 6/6 eyes, cleared by 72 hours.
Other effects:
There were no abnormal systemic signs noted during the observation period.

Any other information on results incl. tables

Individual Results

Animal 1 Animal 2 Animal 3 Animal 4 Animal 5 Animal 6
Cornea 1h 0 0 0 0 0 0
24h 2 0 0 0 0 0
48h 0 0 0 0 0 0
72h 0 0 0 0 0 0
mean 24-72 h 0.67 0.00 0.00 0.00 0.00 0.00 0.11 total mean
Iris 1h 0 0 0 0 0 0
24h 1 0 0 0 0 0
48h 0 0 0 0 0 0
72h 0 0 0 0 0 0
mean 24-72 h 0.33 0.00 0.00 0.00 0.00 0.00 0.06 total mean
Redness 1h 2 2 2 2 2 2
24h 2 2 1 0 1 1
48h 1 0 0 0 0 0
72h 0 0 0 0 0 0
mean 24-72 h 1.00 0.67 0.33 0.00 0.33 0.33 0.44 total mean
Chemosis 1h 1 2 1 1 1 1
24h 0 0 0 0 1 1
48h 0 0 0 0 1 0
72h 0 0 0 0 0 0
mean 24-72 h 0.00 0.00 0.00 0.00 0.67 0.33 0.17 total mean

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met