Registration Dossier

Diss Factsheets

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:
2001
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

Constituent 1
Chemical structure
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

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