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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane
Cas Number:
68413-24-1
Molecular formula:
C24H36O2
IUPAC Name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): CARDOLITE NC-513
- Lot/batch No.: GH-0129
- Expiration date of the lot/batch: 13.07.2014
- Storage condition of test material: room temperature
- Other: the test item was previously considered as 'Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane' (EC number 500-210-7).

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
100%
Day(s)/duration:
24h
Challenge
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

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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.