Ammonium salts of mono- and bis[3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl and/or poly (substituted alkene)] phosphate

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:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Purity: not reported as such

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: 2596, 2820, 2889 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: 19 or 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 63-71%. The humidity was above the targeted upper limit for one day 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:

mean

Time point:

other: 24-, 48-, and 72-hr

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-, 48-, and 72-hr

Score:

0

Max. score:

4

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

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

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

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 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

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

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 6

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 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

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

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

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 corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours. Individual eye irritation scores are presented in Table 1. A summary of mean scores are presented in Table 2.

Other effects:

All animals appeared active and healthy during the study. No biologically significant weight loss occurred in any of the rabbits. Apart from the eye irritation, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.

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	1	0	0	0	1	0	0	0
III. Conjunctivae
A. Redness	1	1	0	0	2	1	0	0	2	1	1	0
B. Chemosis	0	0	0	0	1	0	0	0	1	0	0	0
C.Discharge	1	0	0	0	1	0	0	0	1	1	0	0

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

 

Table 2
Mean Scores for Individual Rabbits
Rabbit Number	Corneal Opacity	Iritis	Conjunctival Redness	Conjunctival Chemosis
3401 3402 3403	0.00 0.00 0.00	0.00 0.00 0.00	0.33 0.33 0.67	0.00 0.00 0.00
^a Calculated from the 24-, 48-, and 72-hour scores.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Irritation was observed in all treated eyes. The treated eye was normal in 2 rabbits by 48 hours and in 1 rabbit by 72 hours.

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. There was no corneal opacity or iritis observed in any treated eye during the study. One and 24 hours after test substance instillation, all treated eyes exhibited conjunctivitis. The treated eye of two rabbits was normal by 48 hours. Conjunctivitis was present in the treated eye of one rabbit at 48 hours. No ocular irritation was observed in the treated eye of this rabbit by 72 hours.