Registration Dossier
Registration Dossier
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EC number: 406-030-4 | CAS number: 105812-81-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: extracted from ECHA database
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- EC Number:
- 406-030-4
- EC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- Cas Number:
- 105812-81-5
- Molecular formula:
- C13H18FNO
- IUPAC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration and vehicle used at induction:
a) intradermal:
- 1% (w/v) in arachis oil BP
- 1% (w/v) in Freund's Complete Adjuvant plus arachis oil BP in ration 1:1
b) Topical induction:
- 25% (W/v) in arachis oil BP
Concentration of test material and vehicle used for each challenge:
5% (w/v) in arachis oil BP.
Challenge
- Concentration / amount:
- Concentration and vehicle used at induction:
a) intradermal:
- 1% (w/v) in arachis oil BP
- 1% (w/v) in Freund's Complete Adjuvant plus arachis oil BP in ration 1:1
b) Topical induction:
- 25% (W/v) in arachis oil BP
Concentration of test material and vehicle used for each challenge:
5% (w/v) in arachis oil BP.
- No. of animals per dose:
- 20
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:
- 5 %
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Signs of irritation during induction:
reactions of grade 2 were noted at 14 test skin sites 1 hr after patch removal and 8 of grade 1 at 24 hr.
However, large areas of pale grey/green-coloured necrosis prevented accurate evaluation of erythema during induction at several skin sites at both the 1 -hr and 24 -hr observations. Other adverse dermal reactions noted were small scattered areas of pale grey/green necrosis, bleeding, small superficial scabs, hardened dark brown-coloured scabs, dried blood and desquamation.
Evidence of sensitisation of each challenge concentration: 1/18
One test group animal was found dead on day 23 and another was killed for humane reasons on day 23 owing to rectal prolapse. The absence of these animals was considered not to affect the integrity of the study.
Small scattered areas of dermal necrosis, accompanied by thickening of the skin, were noted at the test material challenge site of one control group animal at the 24 and 48 hr observations. A small scab was also noted at the test material site of one other control animal at these times. These reactions were attributed to irritancy of the test material.
No skin reaction were noted at the test material challenge sites of any other test or control group animal or at any vehicle control sites of the test and control group animals.
Bodyweight gains of animal in the test group were comparable to those in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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