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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
Study period:
Feb - Mar 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable guideline study with limited information about test item.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

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
Justification for non-LLNA method:
The LLNA method was not available at the time this test was performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): d-alpha Tocopherol

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 - 514 g
- Housing: in Makrolon cages (5 animals per cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: 17.02.1986 To: 14.03.1986

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: 5 % in vaseline
challenge: 1 % in vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Intradermal induction: 0.5 % in soybean oil
epicutaneous induction: 5 % in vaseline
challenge: 1 % in vaseline
No. of animals per dose:
20
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)
- 2nd induction: one week after intradermal induction, dermal inducation (5 % 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 item 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 animals and 20 controls, Pirbright white strain, were used. The initial average body weight for the test group animals was 327 g, that one of the control animals was 333 g. For the dilution of the test concentration of the intracutaneous test soybean oil and for the epicutaneous application paraffinum album were used. The Vitamin E-product was applied in the induction phase in 0.5 % (intracutaneous application) respectively in 5 per cent concentration (epidermal application). The challenge concentration was 1 per cent.

24 and 48 hours after the removing of the patches of the challenge application neither the test nor the control animals showed any skin reactions on the treated skin areas.

According to these test results the test item can be classified as "no skin sensitizer" in the Magnusson-Kligman test on guinea pigs.