Butanamine, N,N-dibutyl-, branched and linear, fluorinated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted before adoption of GLP but well documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

FC-43

IUPAC Name:

FC-43

Details on test material:

- Name of test material (as cited in study report): FC-43
- Lot/batch no.: 137

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

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

Duration of treatment / exposure:

The test material was instilled and the eye was washed after 24 hours to remove any material

Observation period (in vivo):

Ocular tissues were graded for irritation and injury at one hour after instillation. Observations were made on days 1, 2, 3, 4, and 7 after instillation.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after instillation
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Observations at 1, 24, 48, 72, 96, and 168 hours

Score:

0 - 2

Reversibility:

fully reversible

Irritant / corrosive response data:

Mean conjunctivae score after 1 hour was 2. All other observation times showed no irritation in the cornea iris and conjunctivae.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test article was found to be practically non-irritating to the eyes of albino rabbits with no corneal opacity. Mean irritation scores after one hour were zero for all animals.

Executive summary:

The potential eye irritating properties of the test article were investigated using a group of six young adult, New Zealand strain albino rabbits. 0.1 mL of undiluted test article was instilled into the conjunctival sac of the right eye of each animal. The left eye of each animal was untreated, serving as a scoring control. At 24 hours any test article remaining in the eye was removed by rinsing the eye with distilled water. The eyes of the animals were examined at 1, 24, 48, 72, 96, and 168 hours after instillation of the test article and the irritation and description of local effects were recorded. Conjunctivae irritation scores of 2 were observed for all six animals at 1 hour after instillation but were completely resolved 24 hours after instillation. No corrosion, staining of ocular tissue, systemic toxicity or mortality were reported during the test period. Therefore, the test article does not have to be classified and has no obligatory labelling requirements for eye irritation.