1-(3-chlorophenyl)-4-(3-chloropropyl)piperazine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source .

Data source

Reference

Reference Type:

secondary source

Title:

Skin sensitization study of Vinyl Pyrrolidone

Author:

EUROPEAN COMMISSION JOINT RESEARCH CENTRE

Year:

2003

Bibliographic source:

European Union Risk Assessment Report 1-VINYL-2-PYRROLIDONE, RISK ASSESSMENT, 2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

To evaluate the skin sensitizing potential of Vinyl Pyrrolidone in guinea pigs by Buehler test.

GLP compliance:

not specified

Type of study:

Buehler test

Justification for non-LLNA method:

Not specified.

Test material

Test material information

Constituent 1

Reference substance name:

Vinyl Pyrrolidone

Cas Number:

88-12-0

Molecular formula:

C6H9NO

IUPAC Name:

Vinyl Pyrrolidone

Specific details on test material used for the study:

- Name of test material (as cited in study report): N-VP (Vinyl Pyrrolidone)
- Molecular formula (if other than submission substance): C6H9NO
- Molecular weight: 111.1431g/mol
- Substance type: Organic
- Purity; 99.7%

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available.

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

undiluted test substance

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

undiluted test substance

Day(s)/duration:

6 hour

No. of animals per dose:

Test animals-20
Control -10

Details on study design:

Details on study design
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 6 hour
- Test groups:20
- Control group: 10
- Site: The test material was applied under an occlusive dressing to the flanks of
Guinea pigs, and held in place for 6 hours.
- Frequency of applications: The treatment occurred once per week on three
successive weeks
- Duration: 3 weeks
- Concentrations: undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:14 days
- Exposure period: 6 hour
- Test groups:20
- Control group: 10
- Site: The test material was applied under an occlusive dressing to the opposite flanks.
- Concentrations: 0.25 ml as undiluted test substance
- Evaluation (hr after challenge):The application sites scored 24 and 48 hours after removal o

Challenge controls:

Since test material was applied without use of a vehicle, the control group of 10 guinea pigs remained untreated

Positive control substance(s):

yes

Remarks:

historical data on alpha-hexylcinnamaldehyde

Study design: in vivo (LLNA)

Statistics:

No data available.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: Challenge

Hours after challenge:

48

Group:

test chemical

Dose level:

undiluted test substance

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No skin sensitization effects were observed.

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

No skin sensitization effects were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

Vinyl Pyrrolidone (88-12-0) was evaluated for its skin sensitizing potential in guinea pigs by Buehler test. Vinyl Pyrrolidone was considered to be non sensitizing in guinea pigs.

Executive summary:

In the study Vinyl Pyrrolidone was assessed for its possible contact allergenic potential. For this purpose Buehler test was performed on 20 guinea pigs. In induction phase 0.25 ml of test material was applied under an occlusive dressing to the flanks of, and held in place for 6 hours. The treatment occurred once per week on three successive weeks. Since test material was applied without use of a vehicle, the control group of 10 guinea pigs remained untreated. No signs of irritation and no systemic toxicity were observed during the induction phase. After 14 days of rest period. Challenge exposure was performed using 0.25 ml of test material .It was applied under an occlusive dressing to the opposite flanks of all treated and control animals for 6 hours . The application sites scored 24 and 48 hours after removal of the patches. No skin sensitization effects were observed. Therefore Vinyl Pyrrolidone (88-12-0) was considered to be non sensitizing in guinea pigs by Buehler test.