Registration Dossier
Registration Dossier
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EC number: 609-095-9 | CAS number: 352232-17-8
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- na
Test material
- Reference substance name:
- 10-[4-(2-chloroethyl)piperazin-1-yl]-2-thia-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene
- EC Number:
- 609-095-9
- Cas Number:
- 352232-17-8
- Molecular formula:
- C19H20ClN3S
- IUPAC Name:
- 10-[4-(2-chloroethyl)piperazin-1-yl]-2-thia-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene
- Details on test material:
- - Name of test material (as cited in study report): Quetiapine 3rd intermediate (chloro-ethyl thiazepine)
- Physical state: cream-coloured crystalline powder
- Lot/batch No.: 2000/1
- Expiration date of the lot/batch: April 2001
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER (EUROPE) LABORATORIES INC.
- Weight at study initiation: 310-351 g
- Housing: Macrolon cage, size III (42x42x19 cm), 2-3 animals / cage
- Bedding: Laboratory bedding
- Diet (e.g. ad libitum): ad libitum (UNIPLUS standard diet for rabbits produced by AGRIBANDS Europe Hungary)
- Water (e.g. ad libitum): ad libitum, tap water for human consumption containing 50 mg / 100 ml Ascorbic acid
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment)
1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 75 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment)
1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment)
- No. of animals per dose:
- 2 animals / 2 concentrations in preliminary dose range finding study
10 heads (in test groups)
5 heads (in control groups) - Details on study design:
- see under paragraph 'any other information...'
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- patchy, confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- patchy, confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information moderately
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