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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
EC Number:
252-046-8
EC Name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Cas Number:
34455-29-3
Molecular formula:
C15H19F13N2O4S
IUPAC Name:
carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Details on test material:
-Purity: 87%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 2285-2658 g
- Housing: singly housed in suspended stainless steel caging
- Diet: Food: Harlan Teklad Global High Fiber Rabbit Diet® 2031. A designated amount of the diet (approximately 150 grams/day) and a Premium Timothy CubeTM (Ontario Dehy Inc.) were available to each rabbit.
- Water: Filtered tap water was supplied ad libitum.
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 19-22ºC
- Humidity: 40-50%
- Air changes (per hr): 12
- Photoperiod: 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit remained untreated with the test substance and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): One-tenth of a millilitre (0.090 grams)
Duration of treatment / exposure:
single application
Observation period (in vivo):
1, 24, 48, and 72 hours post-instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: a white light source in accordance with Draize, the fluorescein dye evaluation procedure was used in the treated eye at 24 hours to verify the absence of corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 to 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Calculated from the 24-, 48-, and 72-hour scores
Irritant / corrosive response data:
All animals appeared active and healthy and gained body weight during the study. Apart from the eye irritation noted below, there were no other clinical signs observed.
No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbits and discharge (score of 1) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits at 24 hours.

Any other information on results incl. tables

 

#1

#2

#3

Hour

Hour

Hour

1

24

48

72

1

24

48

72

1

24

48

72

I. Cornea

 

 

 

 

 

 

 

 

 

 

 

 

A.Opacity

0

0

0

0

0

0

0

0

0

0

0

0

B.Area

4

4

4

4

4

4

4

4

4

4

4

4

II. Iris

 

 

 

 

 

 

 

 

 

 

 

 

A.Values

0

0

0

0

0

0

0

0

0

0

0

0

III.Conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

A.Redness

0

0

0

0

1

0

0

0

0

0

0

0

B.Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

C.Discharge

1

0

0

0

1

0

0

0

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (score of 1) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits at 24 hours.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of one rabbit and discharge (score of 1) was noted in the treated eye of all three rabbits. Irritation cleared in the treated eye of all rabbits at 24 hours.