Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SR 349
- Physical state: Viscous liquid
- Analytical purity: no data
- Lot/batch No.: HYJ1628
- Expiration date of the lot/batch: Jan 1994
- Storage condition of test material: room temperature in the dard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3 - 3.1kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): SDS Stanrab (P) ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: all rabbits were acclimatised

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
substance was not washed out
Observation period (in vivo):
7 days
1h, 1, 2, 3, 4, 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day1-7
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #2,3
Time point:
other: 1h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1day
Irritation parameter:
chemosis score
Basis:
animal: #2,3
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Other effects:
No signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance was not irritating to the eyes of three rabbits.