Registration Dossier
Registration Dossier
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EC number: 437-930-5 | CAS number: 51553-03-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- method by Magnusson and Klingman
Test material
- Reference substance name:
- -
- EC Number:
- 437-930-5
- EC Name:
- -
- Cas Number:
- 51553-03-8
- Molecular formula:
- Hill formula: C22H23N7O5 CAS formula: C22H23N7O5
- IUPAC Name:
- N-{5-[bis(2-methoxyethyl)amino]-2-[2-(2,6-dicyano-4-nitrophenyl)diazen-1-yl]phenyl}acetamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal: 20% in corn oil
Epidermal: 50% in corn oil
Concentration of test material and vehicle used for each challenge:
1% in corn oil
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Intradermal: 20% in corn oil
Epidermal: 50% in corn oil
Concentration of test material and vehicle used for each challenge:
1% in corn oil
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- hypersensitivity had been induced
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- hypersensitivity had been induced
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 2.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 1 %
Signs of irritation during induction:
Durch purpurne Verfärbung durch die Testsubstanz konnte
nach der intradermalen und epidermalen Induktion das
Auftreten von Erythemen nicht bewertet werden.
Bei zwei Tieren trat nach der intradermalen Injektion eine
Nekrose auf (1 mm Durchmesser).
Purple staining by the test substance prevented scoring for
erythema after the intradermal and epidermal exposure.
Two animals showed signs of necrosis (1mm in diameter)
after the intradermal injection.
Evidence of sensitisation of each challenge concentration:
10(10) experimental group
0(5) control group
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
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