Phosphoric acid, mixed esters with 3,3,4,4,5,5,6,6,7,7,8,8,8 –tridecafluorooctan-1-ol and polysubstituted alkane, mono- and diammonium salts

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 labeling and/or risk assessment.

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

Remarks:

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:

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: 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: 2338, 2442, 2563 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: 12 or 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 60-69%
- 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:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

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

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

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

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

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

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

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

Score:

1

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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

There was no corneal opacity observed in any treated eye during the study. Iritis (score of 1), conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all three rabbits. All animals were free from ocular irritation by 72 hours.

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

Individual Scores for Ocular Irritation
	Rabbit No. 3401 (Female)				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	1	0	0	0	1	0	0	0	1	0	0	0
III. Conjunctivae
A. Redness	2	2	1	0	2	2	1	0	2	2	1	0
B. Chemosis	1	1	0	0	1	1	0	0	1	1	0	0
C.Discharge	2	1	1	0	2	1	0	0	2	1	0	0

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

 

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	1.00 1.00 1.00	0.33 0.33 0.33
^a Calculated from the24-, 48-, and 72-hour scores

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
There was no corneal opacity observed in any treated eye during the study. Iritis (score of 1), conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all three rabbits. All animals were free from ocular irritation 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 observed in any treated eye during the study. Iritis (score of 1), conjunctival redness (score of 1 or 2), conjunctival chemosis (score of 1), and discharge (score of 1 or 2) were observed in the treated eye of all three rabbits. All animals were free from ocular irritation by 72 hours.