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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable, well documented publication, no guideline and no GLP study.

Data source

Reference
Reference Type:
publication
Title:
The Freund's Complete Adjuvant Test and the Open Epicutaneous Test - A Complementary Test Procedure for Realistic Assessment of Allergenic Potential
Author:
Klecak G.
Year:
1985
Bibliographic source:
Curr. Probl. Derm, Vol. 14, pp. 152-171

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The open epicutaneous test represents an animal bioassay conducted with guinea pigs and designated to generate quantitative data. The generation of skin sensitisation data includes a 3 step way. In the pretesting phase the primary irritation threshold concentration of the test substance is determined. The induction phase consists of a 3-week period of daily open applications. The final determination whether sensitisation has occurred or not takes place in the final challenge phase.
GLP compliance:
no
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Information from a well documented publication is available and used in a weight of evidence approach.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 300-450 g

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
100 %, 30 %, 10 %, 3 %, 1 % and 0.3 % / 21 x 0.1 mL
Day(s)/duration:
Day 0 - 20 / 3 weeks (4 weeks)
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
0.025 mL
Day(s)/duration:
Days 21 - 35 / 24, 48, 72 hours
Adequacy of challenge:
other: minimal irritating concentration and some lower primary non irritating concentrations
No. of animals per dose:
Test group: At least 6 animals per dose
Control group: 10 animals per dose
Details on study design:
RANGE FINDING TESTS (Day 1):
Four guinea pigs were used for determination of the primary irritation concentration of the test substance so that non-irritating concentrations may be chosen for challenge.

MAIN STUDY
A. INDUCTION EXPOSURE (Day 0 - 20, epicutaneous)
- No. of exposures: 21 applications (daily for 3 weeks or 5 times weekly during 4 weeks)
- Exposure period: For 3 weeks (4 weeks)
- Control group: No treatment or 21 x 0.1 mL epicutaneous application of vehicle.
- Site: Clipped flank, on an area of 8 cm²
- Frequency of applications: Daily
- Readings: 24 hours after each application
- Duration: 3 weeks (4 weeks)
- Concentrations: if possible 100, 30, 10, 3, 1 and 0.3 %

B. CHALLENGE EXPOSURE (Days 21 - 35, epicutaneous)
- No. of exposures: 2
- Day(s) of challenge: 21 and 35
- Site: On the contralateral flank (2 cm²)
- Concentration: 0.025 mL of minimal irritating concentration and some lower primary non irritating concentrations
- Evaluation (hr after challenge): 24, 48 and 72 hours
Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Results
Key result
Reading:
other: Number of readings is not specified in the study
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an open epicutaneous test (OET) groups of guinea pigs showed no sensitising effect at a concentration of 10 %.
Executive summary:

The skin sensitising potential of the test item was tested in a open epicutaneous test with guinea pigs. The test was conducted on groups of at least 6 male and female animals weighing 300 - 450 g. Daily applications were made for 3 weeks to a clipped 8 cm² area on the flank of each guinea pig. The test sites were not covered and the reactions were read 24 hours after each application. A total of 21 applications of 0.1 mL test material in an unspecified vehicle were made for 21 days. The 10 controls were either left untreated or treated with 0.1 mL test material in an unspecified vehicle for 21 days. At the challenge phase, both the test and control animals were treated at some lower primary non-irritating concentrations. At a test concentration of 10 % no sensitising effect were observed.