Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 16- 19, 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Characteristics: white powder
Storage conditions: room temperature in the original container

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The rabbits were about 2 -3 months old and weighed about 2.5 – 2.8 kg. All animals were clinically observed and 20% of them were weighed: their weight conformed to that required. The animals were housed in the same room in which the treatment was performed.
Animal room controls were set to maintain temperature and relative humidity at 19°C ± 2 and 55 ± 10, respectively. There were 15-20 air changes per hour. The room was illuminated by artificial lighting with a 12 hour circadian cycle (7 a.m. – 7 p.m.).
The diet was available “ad libitum” to the animals.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
Dose administered: 0.1 g/animal
Administation route: ocular
Duration of treatment / exposure:
about 3-4 seconds
Observation period (in vivo):
Observation of the eyes: 1,24,48 and 72 hours after the test article application. After the 24 hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
Number of animals or in vitro replicates:
Number and sex of animals: 3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 60 minutes
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48-72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 60 minutes, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 60 minutes, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 60 minutes, 24, 48, 72 hours
Score:
0
Max. score:
0

Any other information on results incl. tables

Slight conjuntival redness was noted in all rabbits at the reading carried out 1 hour after exposure.

At the subsequent observation, 24 hours later, the same change was still noted in two animals.

Negative results were obtained at the fluorescein staining performed at this time.

No ocular changes were subsequently observed.

Mortality and clinical signs: Neither mortality nor adverse general clinical modifications were seen during the study.

No general clinical signs were noted in any rabbit. Locally, at the application site, slight ocular changes consisting of conjunctival redness were noted up to 24 hours after exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article DTZ62 administered to rabbits as a single ocular application, i sto be considered “non irritant” for the eye.