Amphoteric Fluorinated Surfactant

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:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Remarks:

This study was conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: U.S. EPA Health Effects Test Guidelines OPPTS 870.2400

Deviations:

no

Remarks:

This study was conducted according to guideline in effect at time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: 28 wt%

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: Young adult
- Weight at study initiation: 2304, 2291, 2060 g
- Housing: Singly in suspended stainless steel caging with mesh floors. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 or 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 64-91%. The humidity was above the targeted upper limit for six days during the study. A portable dehumidifier was used to decrease the humidity levels during this time.
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye of each rabbit was not treated with the test substance and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

1, 24, 48, and 72 hours after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated and control eyes of all rabbits remained unwashed.

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: High-intensity white light source and fluorescein stain (24-hour evaluation).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hr scores for redness

Score:

0

Max. score:

4

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hr scores for redness

Score:

0

Max. score:

4

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hr scores for redness

Score:

0

Max. score:

4

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean of the 24-, 48-, and 72-hr scores

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no iritis, corneal opacity, or conjunctival chemosis observed in any treated eye during the study. Conjunctival redness (score of 1) and discharge (scores of 1, 2 or 3) were noted in the treated eye of all three rabbits at the one hour scoring interval. No irritation was observed at 24, 48, or 72 hours. Individual eye irritation scores are presented in Table 1.

Other effects:

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.

Any other information on results incl. tables

Table 1
Individual Scores for Ocular Irritation
	Rabbit No. 3401 (Male)				Rabbit No. 3402 (Female)				Rabbit No. 3403 (Female)
	Hours
	1	24	48	72	1	24	48	72	1	24	48	72
I. Cornea
A. Opacity	0	0^1	0	0	0	0^1	0	0	0	0^1	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	1	0	0	0	1	0	0	0	1	0	0	0
B. Chemosis	0	0	0	0	0	0	0	0	0	0	0	0
C.Discharge	3	0	0	0	1	0	0	0	2	0	0	0

¹2% ophthalmic fluorescein sodium used to verify the absence of corneal opacity.

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Classification not required Criteria used for interpretation of results: other: Directive 67/548/EEC

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
In accordance with the provisions of Directive 67/548/EEC, classification is not required based on the results of this study.
According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required.

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. There was no iritis, corneal opacity, or conjunctival chemosis observed in any treated eye during the study. Conjunctival redness (score of 1) and discharge (scores of 1, 2 or 3) were noted in the treated eye of all three rabbits at the one hour scoring interval. No irritation was observed at 24, 48, or 72 hours.