Registration Dossier
Registration Dossier
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EC number: 921-909-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Maurer optimisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 10% propylene glycol + 90 % physiological saline (intradermal), vaseline (epicutaneous)
- Concentration / amount:
- 0.1 % (w/w) (intradermal)
30 % (w/w) (epicutaneous)
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 10% propylene glycol + 90 % physiological saline (intradermal), vaseline (epicutaneous)
- Concentration / amount:
- 0.1 % (w/w) (intradermal)
30 % (w/w) (epicutaneous)
- No. of animals per dose:
- 20 (control)
20 (testgroup)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: intradermal challenge application
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: intradermal challenge application. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- other: intradermal challenge application
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: intradermal challenge application. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 14.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- skin-sensitising (contact allergenic) potency
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