Registration Dossier

Diss Factsheets

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:
01 Mar - 11 Mar 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroprop-2-enoate
EC Number:
801-260-5
Cas Number:
96383-55-0
Molecular formula:
C11H6ClF13O2
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroprop-2-enoate
Details on test material:
- Name of test material (as cited in study report): Alpha-Chloro C-6 Monomer
- Physical state: colourless liquid
- Lot/batch No.: C61204
- Expiration date of the lot/batch: 31 Aug 2004
- Storage condition of test material: In refrigerator in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
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
- Weight at study initiation: at least 1 kg
- Housing: single housing
- Diet: Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany), approx. 100 g per day. Hay was provided three times per week.
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-21.0 (actual temperature)
- Humidity (%): 37-66 (actual humidity)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
Single application without washing
Observation period (in vivo):
72 h
(scoring after 1, 24, 48, and 72 h)
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
After the 24-h observation a solution of 2% fluorescein in water (pH 7) was instilled to both eyes of each animal to quantitatively determine corneal epithelial damage.

OBSERVATIONS:
Mortality/viability: checked twice daily
Toxicity: at least one daily
Body weight: day of treatment and at termination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
After 1 h all 3 animals showed mild to moderate redness (score 1/2/2). At 24 h redness was reversed in 1 animal and the score of 2 was reduced to 1 in the other 2 animals. After 48 h no redness was observed in any animal.

Any other information on results incl. tables

Table 1: Individual results of eye irritation study.

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

2

1

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

2

 

 

 

 

1

2

0

0

0

24

1

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.3

0.0

0.0

0.0

3

 

 

 

 

1

1

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.67

0.00

0.00

0.00

24

0.67

0.00

0.00

0.00

48

0.00

0.00

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.22

0.00

0.00

0.00

Table 2: Age and body weight of individual animals.

Rabbit No.

1

2

3

Age at start (weeks)

11-13

10-12

10-12

Body weight (gram)

 

 

 

prior to application

2398

2575

2413

at termination

2541

2890

2610

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified