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Diss Factsheets

Administrative data

Description of key information

OECD 406 (guinea pig maximisation test): indication of skin sensitising potential

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
as revised in 1997
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The result of OECD 429 test may be false positive for this substance. So OECD 406 test was performed.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 250 to 300 grams
- Housing: noryl cages measuring 74.3x54.3x25 cm; up to 5 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
100%
Day(s)/duration:
24h
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
50%
Day(s)/duration:
24h
No. of animals per dose:
- control group 10 animals
- test group 20 animals
Details on study design:
RANGE FINDING TESTS:
2 animals used top test the tolerance by single intradermal injection.
Dose volume: 0.1 mL of test item/each site.
Concentrations tested: 100, 50, 20, 10, 5 and 1% in corn oil.
Draize scoring on day 2 and day 6.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48h
- Test groups: undiluted test item
- Control group: vehicle
- Site: injection site
- Frequency of applications: 1
- Duration: 24h after exposure period
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 24h
- Test groups: 50% in corn oil
- Control group: vehicle
- Site: both flanks
- Concentrations: 50% in corn oil
- Evaluation (hr after challenge): 24 and 48

Challenge controls:
vehicle
Positive control substance(s):
no
Positive control results:
not applicable
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: Category 1B (indication of skin sensitising potential) based on EU GHS criteria
Conclusions:
In a GLP-study according to OECD Test Guideline 406, the registered substance was skin sensitising.
Executive summary:

The potential of the test item, Cardolite NC-513, to induce and elicit delayed dermal sensitisation was assessed in the guinea pig using the maximisation test of Magnusson and Kligman. The results obtained in this study indicate that the test item may elicit a sensitisation response in the guinea pig, being there a 50% incidence of reaction observed at challenge (total of the animals showing reaction at 24 and/or 48 hour examination after challenge), following a period of induction exposure to the test item. These results indicate that the test item, Cardolite NC-513, may act as a sensitizer. The validity of the test system was verified with periodic testing of the positive control.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a Guinea Pig Maximisation Test the registered substance induced (after intradermal induction with 20%) skin reaction in 50% of the treated animals. Therefore, the registered substance is classified as skin sensitiser Category 1B (according to Table 3.4.4 of Commission Regulation (EU) No 286/2011).