Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 3, 1990 - September 17, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability 1 is assigned because the study is conducted according to OECD TG 404, in compliance with GLP, without deviations that influence the quality of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(1984)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

EC Number:

916-241-8

Molecular formula:

C13H15N

IUPAC Name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Isobutylquinoleine D 49560
- Appearance: slightly yellow liquid
- Storage condition of test material: At room temperature, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: males: 15 weeks; female: 16 weeks
- Weight at study initiation: males: 3.0-3.1 kg; female: 2.3 kg
- Housing: Animals were housed individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: Free access to pelleted diet for rabbits (Kliba 341, Batch 55/90, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: Free access to tap water.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10x10 cm).

TREATMENT
On day 1, 0.5 mL of the test substance was applied to approx. 6 square centimeters of the intact skin of the clipped area. It was covered with a 3 x 3 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

OBSERVATIONS
- Mortality/Viability and Clinical signs: Daily
- Body Weight: At the start of acclimatization, day 1 (application day) and at termination (day 15)
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and at 7 and 14 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48 and 72 hours (mean)

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

other: 24, 48 and 72 hours (mean)

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Animal #1: slight fissures and desiccated skin by 72 hours and scar formations by day 7; Animal #1 and #2: moderate to slight scales between day 7 to 14; Animal #3: slight scales between day 7 to 14 and desiccated skin by 72 hours

Other effects:

- No acute clinical symptoms were observed
- No mortality occurred
- No adverse effect on the body weight gain was observed

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation study with rabbits, performed according to OECD 404 (1981), irritation was observed, which was fully reversible within 14 days, although scaling was still present. Based on the results of this study, the substance is considered a skin irritant: Category 2 (H315).

Executive summary:

Sec Butyl Quinoline was tested in a skin irritation test in 3 rabbits in accordance with OECD TG 404 (1981) test guideline and according to GLP principles. The mean value for erythema from gradings at 24, 48 and 72 hours after patch removal was 3 in all animals. For oedema, this mean value was 2 in all animals. No corrosive effect was observed. The irritation was fully reversible within 14 days, although scaling was still present. Based on the results of this study, the substance is considered a skin irritant.