Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch #: Vers. 31-33
- Purity: pilot sample
- Storage: room temperature
- Physical state: liquid
- Expiry date: September 1991

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Sex: male
- Weight at study initiation: 2060-2170 g (within ± 20% of mean value)
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum (quality of the drinking water met the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972))
- Acclimation period: 5 days
- Rationale for choice: The albino rabbit is the recommended species for acute eye irritation/corrosion studies

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml

The test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second to prevent loss of the test material.
Duration of treatment / exposure:
eyes were not washed after instillation
Observation period (in vivo):
The ocular reactions were evaluated 1, 24, 48, 72 hours and 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to the OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score after 1 hour = 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Score after 1 hour = 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score after 1 hour = 1
Other effects:
A slight loss of weight was observed in one animal on day 3 (2110 g versus 2130 g at start of test)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information