Registration Dossier
Registration Dossier
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EC number: - | 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Hartley strain albino
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin (intradermal induction); see also under concentration (next box)
- Concentration / amount:
- Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs
Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin (intradermal induction); see also under concentration (next box)
- Concentration / amount:
- Intradermal induction: 0.1 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item)
Topical induction: 0.2 ml of the test formulation (a. 10w/w%; b. 1:1 emulsion of 20w/w% test formulation (test article mixed with FCA) and saline; c. 100% test item) --> exposure for 48 hrs
Challenge: a. 0.1 ml of the test formulations at two concentrations (100% and 50 w/w% in polyethylene glycol 300) --> exposure for 24 hrs
Intradermal dosing: Day 1
Induction dosing: Day 1 + 6
Challenge dosing: Day 1 + 20
- No. of animals per dose:
- 5 (control group) and 10 (test item sensitization group)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% and 50 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% and 50 w/w%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormal clinical signs in any animal in any group.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 100% and 50 w/w-%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormal clinical signs in any animal in any group
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 100% and 50 w/w-%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormal clinical signs in any animal in any group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item was judged to have no sensitization potential.
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