Registration Dossier
Registration Dossier
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EC number: 939-173-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- (3Z)-1-benzofuran-3(2H)-one O-methyloxime
- Cas Number:
- 208711-51-7
- Molecular formula:
- C9H9NO2
- IUPAC Name:
- (3Z)-1-benzofuran-3(2H)-one O-methyloxime
- Reference substance name:
- (3Z)-1-benzofuran-3(2H)-one O-methyloxime
- IUPAC Name:
- (3Z)-1-benzofuran-3(2H)-one O-methyloxime
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and topical
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % in PEG 400
Topical induction: 100 %
1. Challenge: 12 % in PEG 400
2. Challenge: 6 % in PEG 400
Challenge
- Concentration / amount:
- Intradermal induction: 5 % in PEG 400
Topical induction: 100 %
1. Challenge: 12 % in PEG 400
2. Challenge: 6 % in PEG 400
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12%. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6 %
- No. with + reactions:
- 11
- Total no. in group:
- 18
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6 %. No with. + reactions: 11.0. Total no. in groups: 18.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6 %
- No. with + reactions:
- 8
- Total no. in group:
- 18
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6 %. No with. + reactions: 8.0. Total no. in groups: 18.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12 %
- No. with + reactions:
- 3
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12 %. No with. + reactions: 3.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 6 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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