Carbazole

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study based on scientific principles, reproducible test method, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1963

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Delayed hypersensitivity/contact sensitisation: Intradermal injection of the agents into the foot pad for induction in the presence of Freund´s adjuvant, followed by topical/epidermal challenge
(method according to: Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961)

GLP compliance:

no

Type of study:

intracutaneous test

Test material

Test material information

Constituent 1

Reference substance name:

Anthracene

EC Number:

204-371-1

EC Name:

Anthracene

Cas Number:

120-12-7

Molecular formula:

C14H10

IUPAC Name:

anthracene

Details on test material:

commercial (Eastman Kodak), no further data

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: intradermal into each front food pad

Vehicle:

other: acetone-olive oil mixture (no further data)

Induction 2

Concentration / amount:

0.001, 0.01, 0.1, and 1 %

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: acetone-olive oil mixture (no further data)

Challenge 2

Concentration / amount:

0.001, 0.01, 0.1, and 1 %

No. of animals per dose:

no data [note: 6, 16, and 10 were used for 3-methylcholanthrene (MC), BaP and 9,10-dimethyl-1,2-benzanthracene (DMBA), respectively]

Details on study design:

RANGE FINDING TESTS: no data


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 2 - 3 weeks
- Test groups: 4
- Control group: 1
- Site: each foot pad
- Frequency of applications: 1x
- Concentrations: 250 µg (125 µg/0.1 mL)
- Auxiliary agent: emulsion in complete Freund´s adjuvant with saline


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 - 3 weeks after induction
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site: ventral or dorsal shaved skin
- Concentrations: 0.001, 0.01, 0.1,and 1 % (one drop each applied)
- Evaluation (hr after challenge): 24


OTHER:
- Scoring system
according to Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961): from +++ - 0

Challenge controls:

PAH known to be contact sensitisers in this tes system: BaP, MC, and DMBA.

Positive control substance(s):

yes

Remarks:

BaP, MC, and DMBA

Study design: in vivo (LLNA)

Positive control substance(s):

other: Methylcholanthrene and Benz(a)pyrene

Results and discussion

Positive control results:

MC +++ (>= 0.1 %); BaP +++ (>= 0.1 %); DMBA +++ (1 %).
Dose-related intensity of the responses
Cross-reactivity primarily seen at the higher challenge doses.

In vivo (non-LLNA)

Results

Results 1

Hours after challenge:

24

Group:

negative control

Dose level:

0.001 - 1 %

Clinical observations:

reponse - to +- (slight erythema)

Remarks on result:

other: . Hours after challenge: 24.0. Group: negative control. Dose level: 0.001 - 1 %. Clinical observations: reponse - to +- (slight erythema).

Results 2

Hours after challenge:

24

Group:

test chemical

Dose level:

0.001 - 1 %

Clinical observations:

no difference from control

Remarks on result:

other: . Hours after challenge: 24.0. Group: test group. Dose level: 0.001 - 1 %. Clinical observations: no difference from control .

Any other information on results incl. tables

Note: Phenanthrene concomitantly examined also failed to show a sensitising potential.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information