reaction mass of 1,1,1,2,2,3,3,4,4,5,5,6,6,6-tetradecafluoro-hexane and 1,1,1,2,2,3,3,4,5,5,5-undecafluoro-4-(trifluoromethyl)pentane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 January 1991 to 1 February 1991 (In-Life)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

The in-life end date is not as stated in the protocol. This deviation is not considered to have had an adverse effect on the study outcome.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Perfluorohexane

IUPAC Name:

Perfluorohexane

Details on test material:

- Name of test material (as cited in study report): T-5333
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Storage condition of test material: Stored at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo MI
- Age at study initiation: Adult
- Weight at study initiation: 2.2 to 2.6 kg
- Housing: Individually, in screen-bottom stainless steel cages
- Diet (e.g. ad libitum): Measured amount of High Fiber Rabbit Chow #5326 (Purina Mills, Inc.)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8 to 21.7
- Humidity (%): 33 to 40
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From29 January 1991 to 1 February 1991

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

Several seconds during instillation of the test article.

Observation period (in vivo):

72 hours after instillation

Number of animals or in vitro replicates:

2 male, 1 female

Details on study design:

Left eye in each animal served ad an untreated control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: Draize Technique
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Scores for overall irritation were zero at all time points for all animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preperations, the test article does not have to be classified and has no obligatory labeling requirement for eye irritation.

Executive summary:

An eye irritation/corrosion study was done in three New Zealand White albino rabbits (according to OECD 405). 0.1 mL of the undiluted test article was instilled in the conjunctival sac of one of the eyes of each animal. The eyes of the animals were examined at 1, 24, 48, and 72 hours after instillation of the test article and the irritation and description of local effects were recorded. At 72 hours fluorescein (2% fluorescein in water) was instilled to observe corneal epithelial damage. No irritation, corrosion, staining of ocular tissue, systemic toxicity or mortality were observed during the test period. Therefore, the test article does not have to be classified and has no obligatory labelling requirements for eye irritation.