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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Feb - 05 Apr 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
adopted in Nov 2000
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium undecafluorohexanoate
EC Number:
244-479-6
EC Name:
Ammonium undecafluorohexanoate
Cas Number:
21615-47-4
Molecular formula:
C6H4F11NO2
IUPAC Name:
2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
(SPF-Quality)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 2.049 - 2.330 kg (range)
- Housing: individually in cages with perforated floors (56x44x37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g per day, additionally pressed hay three times a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.5 - 24.7
- Humidity (%): 29 - 78
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
28 days
reading time points: 1, 24, 48 and 72 h and 7, 14, 21 days (and/or 28 days in the sentinel animal)
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein; Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: a 20% aqueous solution of the test substance was used
Irritant / corrosive response data:
The corneal injury consisted of opacity (maximum grade 2) in all animals and epithelial damage (maximum fluor area 35%, 65% and 50% of the corneal area). In 2/3 animals corneal injury was reversible within 7 days and persisted until day 21 in the remaining animal. lridial irritation (grade 1) was observed in all animals and was reversible within 72 hours in 1/3 animals and within 7 days in the two remaining animals. The irritation of the conjunctivae consisted of redness (maximum grade 3), chemosis (maximum grade 4) and discharge (maximum grade 3). Redness had completely resolved within 21 and 28 days in 2/3 animals, respectively, and persisted until termination (day 21) in the remaining animal. Chemosis and discharge had completely resolved within 7 days in all animals.
Other effects:
- Lesions and clinical observations: As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent in 1/3 animals 7 and 21 days after instillation. Reduced elasticity of the eyelids was noted in all animals 24 and/or 48 hours and/or 7 days after instillation.
- Other observations: No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Results of eye irritation study.

Alteration

Animal No.

Time (h)

 

1

 

24

 

48

 

72

mean 24/48/72 h

reversible within

Cornea

(opacity)

1

1

2

1

1

1.3

7 days

2

1

1

1

1

1.0

7 days

3

1

1

1

1

1.0

Not reversible within 21 days

Area of

corneal opacity *

1

1

1

2

1

-

-

2

3

3

3

2

-

-

3

3

2

2

2

-

-

Iris

1

0

0

1

1

0.7

7 days

2

1

1

1

0

0.7

72 h

3

1

1

1

1

1.0

7 days

Conjunctivae Redness

1

2

2

3

3

2.7

28 days

2

2

3

3

3

3.0

Not reversible within 28 days

3

2

3

3

3

3.0

21 days

Conjunctivae Chemosis

1

4

3

2

1

2.0

7 days

2

3

3

2

1

2.0

7 days

3

3

2

2

1

1.7

7 days

*Area of cornea involved:

0 = No ulceration or opacity

1 = One quarter or less but not zero

2 = Greater than one quarter, but less than half

3 = Greater than half, but less than three quarters

4 = Greater than three quarters, up to whole area

 

 

 

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: Eye damage Cat. 1 according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this eye irritation study in rabbits the test substance was corrosive to the eye. Although a 20% aqueous solution of the test substance was used in this study, results are considered valid as corrosive properties can also be assumed for the pure test substance. Thus, the test substance is classified as Eye Dam. 1 (H318) according to Regulation (EC) No 1272/2008.