Registration Dossier

Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November1995-January 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study done under OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
F-3014
Batch number 016
Data received 2 October 1995
Description White solid
Storage conditions room temperature

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: 12-20 weeks old
- Weight at study initiation: 2.62-2.86 Kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water (e.g. ad libitum): mains drinking water
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 49-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12-12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 gr
Duration of treatment / exposure:
1 second. The test material (100g) was placed into the cojuctival sac of the right eye, by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, then released.

Observation period (in vivo):
Assessment of ocular damage/ irritation was made approx. 1 hr and 24, 48, and 72 hr following treatment.
Number of animals or in vitro replicates:
1 initial and five additional animals
Details on study design:
see attched file (materials and methods, procedure and interpretation of results)

Results and discussion

In vivo

Results
Irritation parameter:
other: Cornea, Iris and Conjunctivae scores
Basis:
mean
Time point:
other: up to 72 hr observation (24, 48 and 72)
Score:
9
Max. score:
9
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Residual test material was noted around the treated eye of all animals 1 hr after treatment.
No corneal effects were noted during the study
iridial inflammation was noted in four treated eyes 1 hr after treatment. No other iridial effects were noted.
Minimal to moderate conjunctival irritation was noted in all treated eyes 1 hr after treatment. Minimal conjunctival redness persisted in four treated eyes at the 24 hr observation.

Applicant's summary and conclusion

Interpretation of results:
other: Minimal irritant
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material F-3014, produced a maximum group mean score of 9 and was classified as a Minimal Irritant (Class 3 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.
Executive summary:

The test material F-3014, produced a maximum group mean score of 9 and was classified as a Minimal Irritant (Class 3 on a 1-8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbol and risk phrase are required.