4,4,5,5,6,6,7,7,8,8,9,9,9-tridecafluorononan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

EPA OPPTS 870.2400 (Acute Eye Irritation)

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:

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.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

EC Number:

211-477-1

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Cas Number:

647-42-7

Molecular formula:

C8H5F13O

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Details on test material:

-Purity: 99.7%

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: 3250-3615 g
- Housing: Singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet (e.g. ad libitum): 125 g rabbit diet daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light):artificially illuminated (fluorescent light) approximately 12 hour dark/12 hour light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye of each rabbit 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, 72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes remained unwashed

SCORING SYSTEM: Draize scale for scoring ocular lesions. Any other adverse ocular reactions were also noted.

TOOL USED TO ASSESS SCORE: Approximately 1, 24, 48, and 72 hours after administration, the rabbits were examined for evidence of eye irritation. At each observation period, eyes were examined using illumination and magnification and scored for ocular reactions. Fluorescein stain examinations were conducted at the 24-hour and each subsequent evaluation.

Results and discussion

In vivo

Irritant / corrosive response data:

Iritis (score of 1) was observed in the treated eye of 1 rabbit, conjunctival redness (score of 1, 2, or 3) was observed in the treated eyes of 3 rabbits, conjunctival chemosis (score of 1) was observed in the treated eye of 1 rabbit, and discharge (score of 1) was observed in the treated eye of 1 rabbit. Fluorescein stain examinations were negative for corneal injury in the treated eyes of the rabbits throughout the study. The treated eyes of the rabbits were normal by 24 or 48 hours after instillation of the test substance. See Table 1 for Individual Animal Data.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects
	Rabbit Number	Cornea		Iritis	Conjunctiva			Fluorescein Stain
		Opacity	Area		Redness	Chemosis	Discharge
1 Hour	184	0	0	0	2	1	0	NA
	203	0	0	0	2	0	1	NA
	204	0	0	1	3	0	0	NA
24 Hours	184	0	0	0	0	0	0	Neg
	203	0	0	0	1	0	0	Neg
	204	0	0	0	1	0	0	Neg
48 Hours	184	0	0	0	0	0	0	Neg
	203	0	0	0	0	0	0	Neg
	204	0	0	0	0	0	0	Neg
72 Hours	184	0	0	0	0	0	0	Neg
	203	0	0	0	0	0	0	Neg
	204	0	0	0	0	0	0	Neg

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is slightly irritating but does not met the CLP criteria

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).

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. Under the conditions of this study, the test substance produced iritis, conjunctival redness, conjunctival chemosis, and discharge when instilled into the rabbit eye. All ocular irritation reversed by 48 hours.