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): 0.1 mL 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 72 hours since there was no evidence for irritation.
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, 2 and 3
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
iris score
Basis:
animal: #1, 2 and 3
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
2
Remarks on result:
other: no effect
Irritation parameter:
chemosis score
Basis:
animal: # 1 and 3
Time point:
other: 1
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: Redness of Conjuctivae
Basis:
animal: # 1, 2 and 3
Time point:
other: 1 and 24 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 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 set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to eye.
Executive summary:

The acute eye irritation of ITTFEP (purity 82.3%) 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 3065 to 3571 g at the start of the test) 0.1 mL 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. Since there was no evidence for irritaion, the test was terminated after 72 hours. Very slight or slight conjunctival reactions including very slight or slight chemosis (grade 1 or 2) and very slight or slight redness of the conjunctiva (grade 1 or 2) were observed on all animals on day 1; these reactions persisted up to day 2 at latest.

Mean scores calculated for the three animals over 24, 48, and 72 hours were 0 for coronal opacity, 0 for iris lesions, 0.1 for chemosis and 0.3 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 set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to eye.