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Administrative data

Description of key information

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
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.
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.
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
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
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
Positive control results:
no data
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The evaluation of the skin sensitizing potential of D-alpha-Tocopherol is based on two in-vivo studies with the test item and a reliable publication.

The skin sensitizing potential of the test item was assessed using the Guinea pig maximization test. The assays are done according to the OECD guideline 406.

Key Study:

For the GPMT 20 female test animals and 20 controls, Pirbright white strain, were used. For the dilution of the test concentration of the intracutaneous test soybean oil and for the epicutaneous application paraffinum album were used.

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.

Supporting Study:

The first supporting study was done according to the key study. 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.

Supporting Study:

The sensitizing properties of D-alpha-Tocopherol (Purity 87%) was evaluated in the guinea pig maximization test.

20 guinea pigs were used for the test group and 19 guinea pigs were used for the control group.

Sensitization rate was 0/20 and 0/19 in the test and control group, respectively. The test substance was not a sensitizer under the conditions of this study.

The information available on the skin sensitizing potential of the test item show no need for a classification of the test item concerning skin sensitization.


Migrated from Short description of key information:
Skin sensitisation:
Key: not sensitising (GPMT)
Supporting study: not sensitising (GPMT)
Supporting study: not sensitising (GPMT, publication)

Justification for selection of skin sensitisation endpoint:
Reliable guideline study which is the basis for classification.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitization does not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.