Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study with good documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of each animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per left eye
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test substance.
Observation period (in vivo):
The test duration was 14 days for animal #3. Since no effects were observed for animals # 1 and 2, these animals were sacrificed 72 hours after treatment.
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:
Commission directive 93/21/EEC of 27 April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 1 and 2
Time point:
other: 1, 24, 48 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h and days 7, 10, and 14
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
iris score
Basis:
animal: # 1 and 2
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
2
Remarks on result:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h and days 7, 10 , and 14
Score:
0
Max. score:
2
Remarks on result:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal: # 1 and 2
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 48 and 72 hours and day 7
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
other: Redness of Conjuctivae
Basis:
animal: # 1 and 2
Time point:
other: 1, 24, 48, and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: no effect
Irritation parameter:
other: Redness of conjuctivae
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item is not required to be classified as irritating to the eye.
Executive summary:

The acute eye irritation of CTFEP (purity 91.4%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 405 and EU Method B.5 (Griffon 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute eye irritation testing in 3 male rabbits (approx. weight of 2777 to 2920g at the start of the test) 100 mg test item was administered to the conjunctional sac of the left eye after gently pulling the lower lid away from the eyeball. The untreated right eye served as control.

 

The eyes were examined according the EU specifications after addition of fluorescein. Two animals showed no adverse reaction after addition of the test item within 72 hours and were subsequently sacrificed. For the third animal slight chemosis (grade 2), very slight redness of the conjunctivae (grade 1) and clear discharge were observed on day 1; very slight chemosis (grade 1) persisted up to day 7. In this animal alopecia was also recorded between day 2 and 10.

Mean scores calculated for the three animals over 24, 48, and 72 hours were 0 for coronal opacity, 0 for iris lesions, 0.4 for chemosis and 0 for redness of the conjunctiva.

 

There were no remarkable clinical observations during the study.

 

It can be concluded that under the experimental conditions the test substance is non irritant when administered by ocular route to rabbits.

 

According to the classification criteria laid down in the Commission Directive 93/21/EEC the test item is not required to be classified as irritating to the eye.