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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:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation:327-333 g
- Housing: Makrolon cage type IV
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12h dark / 12 h light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal induction: 0.5 % in soybean oil
epicutaneous induction: 10 % in vaseline
challenge: 1 % in vaseline
Challenge
Concentration / amount:
Intradermal induction: 0.5 % in soybean oil
epicutaneous induction: 10 % in vaseline
challenge: 1 % in vaseline
No. of animals per dose:
- range finding test. 15
- main test: 20 test animals, 20 control animals
Details on study design:
RANGE FINDING TESTS: 3 tests were done with 5 guinea pigs each
- group A: intracutaneous application: 0.1, 0.5, 1.0, 2.0 % (vehicle: soybean oil)
- group B: dermal induction: 5, 10 % (vehicle: vaseline)
- goup C: intracutaneous injection of Freund's adjuvans (0.1 ml), in the 3rd week: dermal induction: 0.2 g of a 2.5 and 5% solution

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- 1st induction: 6 intradermal injections (Freund'S Adjuvans, 0.5 % test item, Freund's Adjuvans + 1 % test item)
- 2nd induction: one week after intradermal induction, dermal inducation (10 % in vaseline)
- Exposure period: 48 h
- Test groups: 20
- Control group: 20

B. CHALLENGE EXPOSURE
- Day(s) of challenge: 14 days after last induction
- Exposure period: 24 h
- Concentrations: 1% in vaseline
- Evaluation (hr after challenge): 24, 48 h
Challenge controls:
no data
Positive control substance(s):
no

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1 % in vaseline
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 % in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1 % in vaseline
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

No changes in bodyweight gain were seen. No mortality occurred. No skin reactions were noted after challenge.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to these test results the test item can be classified as "no skin sensitizer" in the Magnusson-Kligman test on guinea pigs.
Executive summary:

The test substance was tested for its sensitization potential in guinea pigs, using the method of B. Magnusson and A. M. Kligman, J. Invest. Dermatol. 52, 268 -276 (1969). First the minimum irritant concentration for the induction application (intracutaneous and epidermal) and the maximum non irritant concentration for the challenge application were estimated in separate tests. For the main test 20 female test animale and 20 controls, Pirbright white strain, were used. The initial average body weight of the test group animals was 333.8 g, that one of the control animals was 314.0 g. The test substance was applied in oily dilutions. 24 and 48 hours after removing of the patches of the challenge application no skin reactions were observed on the test animals as well as on the control animals. According to these test results the test substance can be regarded as a "non sensitizer' for albino guinea pigs.