Registration Dossier
Registration Dossier
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EC number: 213-382-0 | CAS number: 941-69-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECDTG406 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- N-phenylmaleimide
- EC Number:
- 213-382-0
- EC Name:
- N-phenylmaleimide
- Cas Number:
- 941-69-5
- Molecular formula:
- C10H7NO2
- IUPAC Name:
- 1-phenyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Details on test material:
- Purity:>99.9%
.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction
Intradermal injection 0.1% in liquid paraffin
Topical application 1.5% in liquid paraffin
Challenge 0.5% and 0.25% in liquid paraffin
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction
Intradermal injection 0.1% in liquid paraffin
Topical application 1.5% in liquid paraffin
Challenge 0.5% and 0.25% in liquid paraffin
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 0.1% intracutaneous
2nd application: Induction 1.5% semiocclusive
3rd application: Challenge 0.5, 0.25% semiocclusive - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- In this study, PMI is delayed contact hypersensitivity in all 20 animals.
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5 wt% in liquid paraffin
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 wt% in liquid paraffin. No with. + reactions: 20.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: skin sensitizing by animals.
No workers in company production site in Japan receive adverse effect on this substance. - Executive summary:
In a dermal sensitization study with PMI >99.5% provided by NIPPON SHOKUBAI 7Y09 in paraffin oil, female albino guinea-pigs of the Hartrey/Dunkin strain were tested using the method of OECD 406 "Skin Sensitisation".
The numerical scores awarded to the dermal reactions elicted by the challenge application are positve 20/20.
In this study, PMI is delayed contact hypersensitivity in all 20 animals. PMI is classified as the category 1 in accordance with GHS.
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