Carbazole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guideline study, conducted under more stringent test conditions than common today, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Consumer Product Safety Commission, USA; Code of Federal Regulations, Title 16, Section 1500.41

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: exposure period is 24 h, solid TS was suspended (10% carbazole suspension in 0.5% carboxymethyl cellulose), occlusive wrapping, test substance is applied on intact and on scarified skin, scores are taken immediately after removal.

GLP compliance:

no

Remarks:

pre-GLP test

Test material

Test material information

Constituent 1

Reference substance name:

Carbazole

EC Number:

201-696-0

EC Name:

Carbazole

Cas Number:

86-74-8

Molecular formula:

C12H9N

IUPAC Name:

9H-carbazole

Details on test material:

- Name of test material (as cited in study report): Produkt 110 804 received from Rütgerswerke AG
- No further information on test material

Test animals

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

No data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one side of the rabbit's back was shaved the other was shaved and scarified

Vehicle:

other: carboxymethyl cellulose (CMC)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (5 mL)
- Concentration (if solution): 10 % test substance suspension in 0.5% carboxymethyl cellulose

VEHICLE
- Concentration (if solution): ~ 90 %

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: ca 2,5 x 2.5 cm
- Type of wrap if used: no data (but occlusive wrapping)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: according to Draize (ETAD recommendation)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 0 h and 48 h after removal of patch

Score:

0.5

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: score includes readings for intact and for scarified skin.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 0 h and 48 h after removal of patch

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: score includes only readings for intact skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 0h and 48 h after removal of patch

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: score includes only readings for intact skin

Any other information on results incl. tables

Immediately after removal of the patches, one animal showed a score of 1 for erythema and edema. For two other animals, either the erythema score or the edema was 1. All other animals did not show any dermal effects after application of the test substance suspension for 24 h.

 

The effects observed were reversible within 48 h. At the 48 h reading, no irritating effects could be observed any more.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a primary skin irritation test with 6 rabbits, minimal transient irritation effects (score 1 for erythema and edema) were observed on the intact skin of three animals after application of 0.5 mL of a 10% suspension of carbazole in 0.5% carboxymethyl cellulose (50 mg test substance). Effects subsided within 48 h.
The mean score for erythema and edema was 0.167 for the reading immediately after removal of patch. No classification is required according to EU regulations.