Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Magnusson and Kligman maximization test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Age/Weight at study initiation: 1-2month-old; 358 +/-17g (males) or 352 +/-19g (females)
- Housing: 1/cage;
- Diet and water: ad libitum
- Temperature: 22 ± 2°C- Humidity: 30-70 %- Light/dark cycle: 12/12 h – Ventilation: 12 cycles/h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and epicutenous
- Vehicle:
- corn oil
- Concentration / amount:
- Vehicle
- Intradermal route/ induction: corn oil
- Cutaneous route/induction: 80/20 mixture of ethanol/purified water
- Cutaneous route/challenge: acetone
Concentration
- Intradermal route/ induction: 1% in vehicle or vehicle + Freund ’s Complete Adjuvant (FCA)
- C route/induction: 50% in vehicle
- Cutaneous route/challenge: 50% in vehicle
Challengeopen allclose all
- Route:
- other: cutaneous, 24 h occlusive dressing
- Vehicle:
- corn oil
- Concentration / amount:
- Vehicle
- Intradermal route/ induction: corn oil
- Cutaneous route/induction: 80/20 mixture of ethanol/purified water
- Cutaneous route/challenge: acetone
Concentration
- Intradermal route/ induction: 1% in vehicle or vehicle + Freund ’s Complete Adjuvant (FCA)
- C route/induction: 50% in vehicle
- Cutaneous route/challenge: 50% in vehicle
- No. of animals per dose:
- Test groups: 5/sex as controls; 10/sex as treated
- Details on study design:
- - Day 1 = Intradermal route/ induction: 2x 3 injections of 0.1ml each in the scapular area, including: FCA/NACl 50/50; Thiofestermet at 1% in corn oil; Thiofestermet 1% in FCA/NACl (50/50)
- Day 7 = induction of local irritation by lauryl sulfate cutaneous application
- Day 8 = Cutaneous route/ induction: application of the test item for 48h in the same area, using adhesive occlusive dressing
- Day 22 = Cutaneous route/Challenge: on the clipped flank (distant site); application of the test item for 24h using adhesive occlusive dressing
Examinations:
-Scoring of cutaneous reaction 24h and 48h after removal of the dressing for challenge application - Body weight evolution – No histology warranted - Challenge controls:
- yes.
- Positive control substance(s):
- no
- Remarks:
- FCA for induction . No challenging positive controls.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Discrete erythema (Grade 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema (Grade 1).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Discrete erythema (Grade 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Discrete erythema (Grade 1).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Discrete erythema (Grade 1) 24 and 48h after challenge for 1 animal only.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Not classified as sensitizing to the skin.
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