Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. Reliability reduced for read across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
- Name of test material (as cited in study report): Sample No. 910-77

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA, USA
- Age at study initiation: 'young adults'
- Weight at study initiation: 2.27-2.48 kg
- Housing: Wire mesh bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 31%
Duration of treatment / exposure:
eyes not rinsed after instillation
Observation period (in vivo):
24, 48, 72 hours post instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
0.67 - 1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed - 4 animals with score = 1; 2 animals score = 0 at 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
0.67 - 1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed - 5 animals with score =1; 1 animal with score = 0 at 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
2 - 3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 & 72 h
Score:
2 - 3.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: not rinsed

Applicant's summary and conclusion

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