9H-Carbazole-9-propanoic acid, 3-amino-1,2,3,4-tetrahydro-, (3R)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid

EC Number:

923-144-4

Cas Number:

1182722-58-2

Molecular formula:

C15 H18 N2 O2

IUPAC Name:

3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 5.5-8 months
- Weight at study initiation: 2.9-3.0 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: test item moistened with water

Controls:

other: the surrounding untreated skin served as control

Amount / concentration applied:

0.5 g/patch and animal
4000 mg of the test compound were mixed with 4 ml water, 1000 mg of this paste were applied per animal

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: gauze patch, the patch was held in contact with the skin by means of a semi-occlusive dressing (no further information available)

REMOVAL OF TEST SUBSTANCE
- Washing: the patch was removed and the skin sites were evaluated (no further information available)
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

No systemic intolerance reactions were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

In an acute skin irritation study according to OECD TG 404 the test substance was applied for 4 hours to the shaved skin of 3 male rabbits. No rabbit showed any substance-related lesions at the examination time-points 1, 24, 48 and 72 hours after patch removal. No systemic intolerance reactions were observed.