2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione

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 safety assessment report

Data source

Reference

Reference Type:

secondary source

Title:

European Union Risk Assessment Report 1-VINYL-2-PYRROLIDONE

Author:

EUROPEAN COMMISSION JOINT RESEARCH CENTRE

Year:

2003

Bibliographic source:

European Union Risk Assessment Report 1-VINYL-2-PYRROLIDONE; EUROPEAN COMMISSION JOINT RESEARCH CENTRE; Final Report, 2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: According to contemporary regulatory protocols.

Principles of method if other than guideline:

The Buehler test was performed in guinea pigs to determine the sensitization potential of test chemical 1-ethenylpyrrolidin-2-one (CAS No: 88-12-0) according to contemporary regulatory protocols under an occlusive condition.

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:

1-ethenylpyrrolidin-2-one

Cas Number:

88-12-0

Molecular formula:

C6H9NO

IUPAC Name:

1-ethenylpyrrolidin-2-one

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 1-ethenylpyrrolidin-2-one
- Molecular formula: C6H9NO
- Molecular weight: 111.1431 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: C=CN1CCCC1=O
- InChI: 1S/C6H9NO/c1-2-7-5-3-4-6(7)8/h2H,1,3-5H2

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:

Concentration: 100%
Amount: 0.25 ml

Day(s)/duration:

6 hours

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

Concentration: 100%
Amount: 0.25 ml

Day(s)/duration:

6 hours

Adequacy of challenge:

not specified

No. of animals per dose:

20

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period:6 hours
- Test groups:20
- Control group:10
- Site: flanks
- Frequency of applications: once per week on three successive weeks
- Duration: 6 hours
- Concentrations: 100% (0.25 ml)

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Fourteen days after the final induction application,
- Exposure period:6 hours
- Test groups:20
- Control group:10
- Site: opposite flanks
- Concentrations: 100% (0.25 ml)
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

The control group of 10 guinea pigs remained untreated.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%(0.25 ml)

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No signs of irritation and no systemic toxicity were observed.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

Although a concurrent positive control assay was not performed, the laboratory had obtained a positive result in a Buehler test using α-hexylcinnamaldehyde within 6 months of this test, thus validating the sensitivity of the assay protocol.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material 1-ethenylpyrrolidin-2-one (CAS No: 88-12-0) was considered to be not sensitizing to the skin of guinea pigs in a Buehler test.

Executive summary:

The Buehler test was performed in guinea pigs to determine the sensitization potential of test chemical 1-ethenylpyrrolidin-2-one (CAS No: 88-12-0) according to contemporary regulatory protocols under an occlusive condition.

 

During induction, 20 guinea pigs received undiluted 0.25 ml of 1-ethenylpyrrolidin-2-one on the flanks under an occlusive dressing and held in place for 6 hours. The treatment occurred once per week on three successive weeks. Since 1-ethenylpyrrolidin-2-one was applied without use of a vehicle, the control group of 10 guinea pigs remained untreated.

 

After 14 days of the final induction application, animals were challenged on opposite flanks to the for 6 hours under occlusive condition and application sites scored 24 and 48 hours after removal of the patches.

 

No signs of irritation and no systemic toxicity were observed during the induction and challenge phase. Therefore the chemical 1-ethenylpyrrolidin-2-one (CAS No: 88-12-0) was considered to be not sensitizing to the skin of guinea pigs.