Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide

Eye irritation

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 guideline

Test guideline 1

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.

Test guideline 2

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.

Test guideline 3

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

Test material information

Constituent 1

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:

N-(carboxymethyl)-N,N-dimethyl-3-{[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfonyl]amino}propan-1-aminium 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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.