Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 04, 1996 through July 04, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylpyrrolidone
- Physical state: colorless liquid at room temperature
- Analytical purity: 99.7%
- Lot/batch No.: out of tank 300
- Storage condition of test material: refrigerator

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH - Wiga, Kisslegg, FRG
- Age at study initiation: young adult
- Weight at study initiation: 320 - 410 g
- Housing: Makrolon, type IV cage, 5 animals per cage
- Diet (e.g. ad libitum): Kliba Labordiat 341 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 6 days before the beginning of the study in the laboratory for dermal toxicity

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.25 ml of undiluted test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.25 ml of undiluted test substance
No. of animals per dose:
10 animals in control group, 20 animals in test group
Details on study design:
RANGE FINDING TESTS: Based on the results of a pre-test, 0.25 ml of undiluted test substance was chosen as the highest volume that can be applied without toxicity to the test animals. To ensure sufficient saturation of the gauze, the normal 6 layers were reduced to 3.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: one test group
- Control group: yes, no treatment on controls
- Site: anterior left flank
- Frequency of applications: one application per week; days 0, 7 and 14 on the same application area
- Duration: 6 hours
- Concentrations: undiluted test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the third induction
- Exposure period: 6 hours
- Test groups: one test group
- Control group: yes, untreated
- Site: right flank
- Concentrations: undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after the removal of the patch

Positive control substance(s):
yes
Remarks:
historical data on alpha-hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
untreated
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: untreated. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
untreated
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: untreated. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted test substance
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on thre results of this study, it ws concluded that vinylpyrrolidone does not have a sensitizing effect on the skin of the guinea pig in the Buehler Test under the test conditions chosen.
Executive summary:

The substance Vinylpyrrolidone was tested for its sensitizing effect on the skin of the guinea pig in the Buehler test based on the method of Buehler, E.V. (1965). During the induction phase the undiluted test substance did not cause any skin reactions in the test group animals. A challenge was performed 14 days after the third induction. After the challenge with the undiluted test substance no skin reactions could be observed in the test group and control group animals.