Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
An adequate in vivo study was conducted on the test article prior to the requirement for in vitro data.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 November 2001- 28 January 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: T-7600
- Physical state: solid
- Composition of test material, percentage of components: >97% 2-Propenoic acid, 2-[Methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester], <2% water, < 0.01% Phenothiazine
- Lot/batch no.: Lot 1
- Expiration date of the lot/batch:06 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White, albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old.
- Weight at study initiation:1319-1747 grams
- Housing:Individually in labelled cages with performated floors.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial light/ 12 hours dark
IN-LIFE DATES: From: 19 November 2001 To: 26 November 2001

Test system

Controls:
other: no control animals were used, but the other untreated eye served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 54.9 mg (54.6-55.3 mg) (a volume of approximately 0.1 ml)
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used.
Duration of treatment / exposure:
Duration of treatment lasted only a couple of seconds during instillation of the test substance.
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
3 animals/sex/dose
Details on study design:
SCORING SYSTEM:Corneal irritation (and area of cornea involved), Iritis, Conjuctival irritation (including scores for chemosis and discharge).
TOOL USED TO ASSESS SCORE: After the observation period, 2% fluorescein in water was instilled into both eyes of each animals to quantitatively determine corneal epithelial damage.

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Remarks:
mean value redness scores for each animal
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.7 - 1.3
Reversibility:
fully reversible within: 7 days (72 hours in one animal)
Irritant / corrosive response data:
see table 1 : Individual Eye Irritiation Scores

see table 2 : Mean Value Eye Irritiation Scores

Any other information on results incl. tables

Table 1: Individual Eye Irritation Scores

Animal #958

 

Cornea

Iris

Conjunctivae

 

Time after dosing

Opacity (0-4)

Area (0-4)

Fluor area (%)

 (0-2)

Redness (0-3)

Chemosis (0-4)

Discharge (0-3)

Comments

1 hour

0

0

0

0

2

1

1

Remnants of test substance in eye

24 hours

0

0

0

0

2

0

0

 

48 hours

0

0

0

0

1

0

0

 

72 hours

0

0

0

0

1

0

0

 

7 days

0

0

0

0

0

0

0

 

 

Animal #960

 

Cornea

Iris

Conjunctivae

 

Time after dosing

Opacity (0-4)

Area (0-4)

Fluor area (%)

 (0-2)

Redness (0-3)

Chemosis (0-4)

Discharge (0-3)

Comments

1 hour

0

0

0

0

2

1

1

Remnants of test substance in eye

24 hours

0

0

0

0

2

0

0

 

48 hours

0

0

0

0

1

0

0

 

72 hours

0

0

0

0

1

0

0

 

7 days

0

0

0

0

0

0

0

 

 

Animal #963

 

Cornea

Iris

Conjunctivae

 

Time after dosing

Opacity (0-4)

Area (0-4)

Fluor area (%)

 (0-2)

Redness (0-3)

Chemosis (0-4)

Discharge (0-3)

Comments

1 hour

0

0

0

0

2

1

1

Remnants of test substance in eye

24 hours

0

0

0

0

1

0

0

 

48 hours

0

0

0

0

1

0

0

 

72 hours

0

0

0

0

0

0

0

 

7 days

0

0

0

0

0

0

0

 

Table 2: Mean Value Eye Irritation Scores

Animal #

Corneal opacity

Iris

Conjunctivae Redness

Conjunctivae Chemosis

958

0

0

1.3

0

960

0

0

1.3

0

963

0

0

0.7

0

Applicant's summary and conclusion

Interpretation of results:
other: The test article has no obligatory labeling requirement for eye irritation.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article has no obligatory labelling requirement for eye irritation according to EC criteria for classification and labelling requirements.
Executive summary:

The eye irritation potential of T-7600, C4 -Acrylate, was evaluated in 3 male rabbits. The study was carried out based on the following guidelines: OECD 405 and EC Commission Directive 92/69/EEC. Single samples of approximately 55 mg of the test article (volume of 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. The test substance cause irritation of the conjunctivae, shown was redness, chemosis and discharge. The irritation and completely resolved within 72 hours in one animal and within 7 days in the other animals. Remnants of the test substance were present in the eyes of all animals on day 1.

Based on the results of the study, the test article has no obligatory labelling requirement for eye irritation according to EC criteria for classification and labelling requirements.