Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on scientific principles, reproducible test method

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

Reference
Name:
Unnamed
Type:
Constituent
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)

Inductionopen allclose all
Route:
other: intradermal into each front food pad
Vehicle:
other: acetone-olive oil mixture (no further data)
Concentration / amount:
0.001, 0.01, 0.1, and 1 %
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone-olive oil mixture (no further data)
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 test system: BaP, MC, and DMBA.
Positive control substance(s):
yes
Remarks:
BaP, MC, and DMBA

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)

Resultsopen allclose all
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).
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