Vinyl neononanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to an U.S.E.P.A. TSCA Testing Guideline in compliance with the GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

As per IUCLID5 Sections 1.1. - 1.4.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy young adult rabbits were obtained from J. Leslie Furs, American Fork, Ut. that weighted 2.0 — 4.0 kg at time of dosing. The animals were acclimated for 8 days before being placed on study. Rabbits were Individually housed in stainless steel, wire mesh bottom cages. Animal room air was 100% fresh with not less than 10 air changes per hour. The temperature was maintained within protocol limits of 61 — 70°F and relative humiditywas 40 — 60%. Light: 12/12 hour, light/dark cycle was maintained. Fresh certified Agway rabbit feed was provided ad libitum and Fresh potable water was provided ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent untreated skin site

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6

Details on study design:

Approximately 19 hours prior to dermal administration, the hair was clipped from the dorsal area of the animals. Six rabbits were dosed with 0.5 ml of vinyl neononanoate on one intact skin site. The test substance was applied to the skin and covered with a gauze patch which was securely taped in place with hypoallergenic tape. The animals were then wrapped with an occlusive impervious, non—reactive rubberized material and securely taped in place for 4 hours. The animals were then unwrapped and the skin wiped with an absorbent pad to remove any remaining test substance. Observations for skin irritation were made at prescreen, within sixty minutes of compound removal (approximately 4 hours after dosing), 24 hours, 48 hours, 72 hours following patch removal and on Day 7, 10 and 14 of the study. Rabbit body weights were taken within 48 hours of receipt and prior to dosing. All animals were sacrificed following the day 14 scoring period.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hours

Score:

3

Max. score:

3

Irritant / corrosive response data:

Mean dermal irritation scores reached their maximum at 24 hr The scores were 1.7 for erythema and 1.3 for edema. At study termination the scores were 0.7 for erythema and 0.7 for edema. Begining at day 10 dried skin was observed at the test site in two of the animals. This dried skin remained throughout the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Based on the classifications for the observation intervals listed vinyl neononanoate is considered to be a moderate skin irritant under the occlusive conditions of this test.

Executive summary:

An U.S.E.P.A. OTS skin irritation Testing Guideline study was conducted on vinyl neononanoate under the GLP regulations. Based on the classifications for the observation intervals in this study vinyl neononanoate is considered to be a moderate skin irritant under the occlusive conditions of this test.