Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 November 2007 to 07 December 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with OCED test guidelines in compliance with GLP and reported with a valid GLP certificate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Identification: DUSANTOX 86, Certificate of analysis No. 040707/A9Batch number: 005/07Storage conditions: The test article was maintained in a dark package, in the room No. 252 (at room temperature) of the Toxicology laboratory, where it was prepared for the administration. Long term storage: protected against sunlight. Stable: for 24 months.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
NZW (albino) rabbits from SCPV Nitra, SRNumber: 3Initial weight: > 3kgSource: VŰŽV Nitra, SlovakiaHousing conditions: Animals were housed individually in metallic cages. Environment: Environmental control for the animal room was set to maintain 18 ± 3°C, a relative humidity of 55 ± 10% a minimum of 10 air changes/hour. Lighting was artificial, the sequence being 12h light, 12h dark. Acclimation: 20 days.Diet: A standard certified laboratory diet (supplier Top Dovo Dobrá Voda) was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants. Water: Ad libitum.Identification of animals: The animals were marked by serial numbers 1 – 3. These numbers were placed on cages.

Test system

Vehicle:
other: olivae oleum raffinatum
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Dusantox 86 (100 mg) was pulverized, moistened sufficiently with olivae oleum raffinatum and apply to right eye. Vehicle Article: Olivae oleum raffinatum, Certificate of analysis No 625/539/64/2007 Lot Number: L706203
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits (sex not specified).
Details on study design:
TEST PERFORMANCEBefore the study animals were quarantined for 20 days in the conditions identical to the conditions during the experiment. Both eyes of the rabbits were examined within 24 hours before beginning of the test. Test material was placed in amount of 100 mg of Dusantox 86 in the conjunctival sac of rabbit’s right eye. The left eye was served as control. The eyes in all rabbits were examined and score for signs of irritation in the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours after test substance application. Examination of reactions were facilitated by used of hand lamp and magnifying glass. Application of the test articleDusantox 86 (100 mg) was pulverized, moistened sufficiently with olivae oleum raffinatum and apply to right eye. EvaluationChanges of rabbits’ eyes were described and graded according to OECD No 405: Grading of ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 & 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 & 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Some blood vessels were hyperacmic (injected) in conjunctivae of all rabbits 1 hour after Dusantox 86 application. This change had continued in one rabbit (No.2) 24 hours after application and lids of rabbits No.1 and 3 had swollen above normal in the same time. All changes had value of 1 grad. Eye of all rabbits were normal 48 hours after application of test article.

Any other information on results incl. tables

Protocol 1 – Examination of rabbits 24 hours before beginning of the test

Date

Rabbit No

Results of examination

19.11.2007

1

No clinical changes, Eyes : No ocular lesions

19.11.2007

2

No clinical changes, Eyes : No ocular lesions

19.11.2007

3

No clinical changes, Eyes : No ocular lesions

 

Protocol 2 – Body weight of animals

Rabbit No

Date

Initial body weight (kg)

Date

Body weight at the end of the test (kg)

1

19.11.2007

4.13

23.11.2007

4.17

2

19.11.2007

3.84

23.11.2007

3.85

3

19.11.2007

3.40

23.11.2007

3.42

 

Protocol 3 – Results of eyes examination

Rabbit No

Time after application (hours)

Grading of ocular lesion

Date

Cornea

Iris

Conjunctivae

Lids (swelling)

Issue

1

1

0

0

1

0

0

20.11.2007

24

0

0

0

1

0

21.11.2007

48

0

0

0

0

0

22.11.2007

72

0

0

0

0

0

23.11.2007

2

1

0

0

1

0

0

20.11.2007

24

0

0

1

0

0

21.11.2007

48

0

0

0

0

0

22.11.2007

72

0

0

0

0

0

23.11.2007

3

1

0

0

1

0

0

20.11.2007

24

0

0

0

1

0

21.11.2007

48

0

0

0

0

0

22.11.2007

72

0

0

0

0

0

23.11.2007

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Dusantox 86 had not apparent irritant or corrosive effects on eyes of NZW rabbits.
Executive summary:

Test article was applied in a single does to right eye of the rabbits. The left eye was used as the control. The degree of eye irritation was evaluated scoring lesions of conjunctiva, cornea, iris and lids at 1, 24, 48 and 72 hours after application. Dusantox 86 had not apparent corrosive or irritation effect on rabbits eyes. No classification and labelling is applicable.