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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Both intact, shaved skin and abraded shaved skin was tested.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

Scoring occured at patch removal and again after 72 hours.

Details on study design:

TEST SITE
- Area of exposure: Back
- Type of wrap if used: Saran wrap
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24
SCORING SYSTEM:Erythema and edema 0-4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Time point:

other: Observations at 24 and 72 hours

Score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Irritation scores of zero were seen at each observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The results of the investigation shed that FC-43 produces no skin irritation. Scores of zero were obtained at both the 24-hour and 72-hour scoring intervals.

Executive summary:

A primary skin irritation study was performed with the test article using six New Zealand albino rabbits. The backs of the rabbits were clipped free of hair using electric clippers on the day prior to the test. Four test sites, two intact and two abraded, were utilized on the back of each rabbit. The abraded sites were prepared by making minor skin incisions through the stratum corneum, but were not deep enough to disturb the derma. Volumes of 0.5 mL of undiluted test article were introduced under two-inch square gauze patches taped to the exposure sites. The trunk of each animal was then wrapped with Saran Wrap secured with masking tape. After 24 hours of exposure the wrappings were removed and the skin sites were scored for erythema and edema on scales from 0 to 4 for each. The sites were then washed to remove any residual test article. Scoring was repeated at 72 hours an a combined average for both intact and abraded skin over both time periods was calculated. The results of the study showed that the test article produced no skin irritation. Scores of zero were obtained at 24 and 72 hours of observation.