Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2000-01-25 into 2000-02-04
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: B5 Acute toxicity, Eye irritation OECD 405 Order of Ministry of the Health of Czech Republik No. 251/1998 Coll, B.5 Acute toxicity, Eye irrition
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Nature of substance: The sample was applied in the form of undiluted liquid.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Spolek chovatelú Hradec králové
- Age at study initiation:
- Weight at study initiation: over 2.5 kg
- Housing: individual cage, climatization ,
- Diet (e.g. ad libitum): ad libidum
- Water (e.g. ad libitum):ad libidum
- Acclimation period:
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye is control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
exposure 24 hours
Observation period (in vivo):
The clinical eye examination was carried out in the periods
in 1, 24, 48 and 72 hours after application of the sample.
In 1 hour after application the eye reactions were
considered without the flush of the eye with water. In 24
hours the assessment was carried out after wary flush of the
eye with water. The examination of the cornea mesh defect
was carried out after decolouration with fluorescein. The
reaction after 72 hours after application was assessed by
using of fluorescein.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
issue
Basis:
animal: 19, 16, 17
Time point:
other: 1 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
chemosis score
Remarks:
chemosis
Basis:
animal: 19, 16, 17
Time point:
other: 1
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal: 19, 16, 17
Time point:
other: 1
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal: 19, 16, 17
Time point:
other: 1
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 day.
Other effects:
The clinical eye examination was carried out in the periods in 1, 24, 48 and 72 hours after application of the sample. In 1 hour after application the eye reactions were considered without the flush of the eye with water. In 24 hours the assessment was carried out after wary flush of the eye with water. The examination of the cornea mesh defect was carried out after decolouration with fluorescein. The reaction after 72 hours after application was assessed by using of fluorescein. Results: In 1 hour after exposure a slight redness was observed at the first and third animals and slight ophthalmorrhoea was was observed at first animal. No observable changes was noted during the observation period - in 24, 48 and 72 hours after application of the sample among all animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
Average Eye Irritation Index : 2