Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
23. Dec. 1989 - 01. Jan. 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles (no data on test substance purity).

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data on test substance purity)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm Laboratories Limited, Derby, UK

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: straw colored liquid
- Analytical purity: not given, responsibility of the sponsor
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.12 - 3.29 kg
- Housing: individual housing in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19
- Humidity (%): 43 - 64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48, 72 hours
Number of animals or in vitro replicates:
2 male and 1 female
Details on study design:
SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(out of all 3 animals)
Time point:
other: mean over 24 m 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
(out of all 3 animals)
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2 and animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No corneal or irridal effects were noted. Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation and one treated eye at the 48-hour observation. Treated eyes appeared normal 48 to 72 hours after treatment.

Any other information on results incl. tables

Table 1: Results of eye irritation study.       
Rabbit # Time [h] conjunctivae   iris cornea   conjunctivae   iris cornea
redness swelling redness swelling    
1 1 2 1 0 0  
24 1 1 0 0
48 1 1 0 0
72 0 0 0 0
average 0,7 0,7 0,0 0,0 Time to reversion (h)  72,0 72,0 0,0 0,0
2 1 2 2 0 0    
24 1 1 0 0
48 0 0 0 0
72 0 0 0 0
average 0,3 0,3 0,0 0,0 Time to reversion (h) 48,0 48,0 0,0 0,0
3 1 2 1 0 0    
24 1 0 0 0
48 0 0 0 0
72 0 0 0 0
average 0,3 0,0 0,0 0,0 Time to reversion (h)  48,0 0,0 0,0 0,0
       
Time [h] conjunctivae   iris cornea
  redness swelling     avg. time to reversion 56,0 40,0 0,0 0,0
average
score
1 2,00 1,33 0,00 0,00  
24 1,00 0,67 0,00 0,00
48 0,33 0,33 0,00 0,00
72 0,00 0,00 0,00 0,00
24+48+72 0,44 0,33 0,00 0,00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified