reaction mass of mixed (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphates, ammonium salt

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EEC Methods for the Determination of Toxicity Method B.5 Directive 92/69/EEC

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: Not reported
- Weight at study initiation: 2402, 2734 & 2657 g
- Housing: Singly in stainless steel, wire-mesh cages suspended above cage boards. Enrichment (e.g., toy) was placed in each cage
- Diet (e.g. ad libitum): Approximately 125 grams of Rabbit LabDiet® 5322 daily during the study
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22ºC
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): approximate 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):

Approximately 30 to 60 seconds after exposure; then approximately 1, 24, 48, and 72 hours after treatment. One rabbit was further examined 7 and 14 days 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: Illumination and magnification, and fluorescein stain (24-hour and each subsequent evaluation).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: range

Time point:

other: 1 hour to 14 days

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

other: range

Time point:

other: 1 hour to 14 days

Score:

0 - 1

Reversibility:

fully reversible within: 24 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: range

Time point:

other: 1 hour to 14 days

Score:

1 - 2

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

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 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance.
The ocular scores from individual animals with respect to observation time are presented in Table 1. Mean ocular scores calculated in accordance with EEC/GHS are presented in Table 2.

Other effects:

Two of the 3 rabbits pawed the treated eye after instillation of the test substance. One rabbit exhibited hair loss around the eye at 7 days. No clinical signs of systemic toxicity were observed and no body weight loss occurred.

Any other information on results incl. tables

Table 1
Individual Rabbit Ocular Irritation Scores Following Treatment with Test Substance
Reading	Rabbit Number	Cornea		Iritis	Conjunctiva			Fluorescein Stain
		Opacity	Area		Redness	Chemosis	Discharge
1 Hour	341a 370 372	0 0 0	0 0 0	1 0 1	1 1 1	1 1 1	2 2 2	NA NA NA
24 Hours	341 370 372	0 0 0	0 0 0	0 0 0	0 1 2	0 0 1	0 2 2	NEG NEG NEG
48 Hours	341 370 372	0 0 0	0 0 0	0 0 0	0 0 1	0 0 1	0 0 1	NEG NEG NEG
72 Hours	341 370 372	0 0 0	0 0 0	0 0 0	0 0 1	0 0 1	0 0 0	NEG NEG NEG
7 Days	341 370 372	-- -- 0	-- -- 0	-- -- 0	-- -- 1	-- -- 0	-- -- 1	NA NA NEG
14 Days	341 370 372	-- -- 0	-- -- 0	-- -- 0	-- -- 0	-- -- 0	-- -- 0	NA NA NEG
NA = Not Applicable NEG = Negative for corneal injury -- = Not evaluated since all ocular irritation cleared prior to this timepoint a = Initial rabbit tested

 

Table 2
Mean Scoresa for Ocular Responses for Individual Rabbits
Rabbit Number	Corneal Opacity	Iritis	Conjunctival Redness	Conjunctival Chemosis
341 370 372	0 0 0	0 0 0	0 0.33 1.33	0 0 1.0
a  24hr + 48 Hr + 72hr/3. Calculated according to EEC/GHS.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.

Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. Two of the 3 rabbits pawed the treated eye after instillation of the test substance. 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 3 rabbits. Additionally, iritis (score of 1) was observed in the treated eye of 2 rabbits. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. The treated eye of the rabbits was normal by 24 hours, 48 hours, or 14 days after instillation of the test substance. No clinical signs of systemic toxicity were observed, and no body weight loss occurred. One rabbit exhibited hair loss around the eye at 7 days. Under the conditions of this study, the test substance produced slight iritis and conjunctivitis when instilled into the rabbit eye. All irritation cleared by 14 days.