Methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate

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: well-documented GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate

EC Number:

700-424-2

Cas Number:

6872-10-2

Molecular formula:

C14 H17 N O2

IUPAC Name:

methyl 1,3,3-trimethyl-2-methylidene-2,3-dihydro-1H-indole-5-carboxylate

Details on test material:

- Name of test material (as cited in study report): Carboxytrimethylbase, roh, feucht
- Lot/batch No.: 1H
- Appearance: black liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, United Kingdom
- Strain: HC: NZW
- Sex: female
- Weight at study initiation: mean 3.3 kg
- Housing: individually in stainless steel cages
- Diet and water: ad libitum
- Acclimation period: at least 14 days the animals were kept in the quarantine station

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): approx. 50%
- Air changes (per hr): 10 times
- Photoperiod: 12 hours light/ dark cycle; artificial illumination

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral skin area not treated with test compound served as control.

Amount / concentration applied:

500 µl

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
Approx. 24 hours before the test, fur was removed by clipping (electric hair clipper) from the dorsal area of the trunk (6 x 6 cm). 500 µl of the test compound was applied to a hypoallergenic patch. A further patch was moistened with water (negative control). The patches prepared in this way were placed on the opposite dorsal areas of the trunk of each animal and were losely held in contact with the skin by means of semiocclusive dressing for the duration of the exposure period. After the exposure period the dressings and patches were removed.
- Area of exposure: approx. 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the patches the exposed skin areas were carefully washed with water.

SCORING SYSTEM: Draize-scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: overall at 24, 38 and 72 h

Score:

0

Max. score:

4

Other effects:

Not reported.

Applicant's summary and conclusion

Executive summary:

An OECD TG 404 -study for evaluating skin irritation/ corrosion properties of the test substance was conducted on 3 female rabbits. Dermal skin reactions were assessed according to Draize 24, 48 and 72 hours after dermal exposure of 500 µL of the unchanged test substance for 4 hours under semiocclusive dressings.

The study showed that the test substance was not irritating to the skin of rabbits.