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Administrative data

Endpoint:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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: crem coloured crystalline powder
- Lot/batch No.: 2000/1
- Expiration date of the lot/batch: April, 2001
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeder: Ferenc Sándor, address: Vörös Hadsereg 131, Kartal, H-2173, Hungary
- Age at study initiation: adult
- Weight at study initiation: 2394-2703 g
at study termination 2530-2840 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, UNIPLUS standard diet for rabbits (produced by AGRIBRANDS Europe
- Water (e.g. ad libitum): ad libitum, tap water (for human cosumption) from automatic self-supplying watering system
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of each animal served as control
Amount / concentration applied:
TEST MATERIAL
0.5 g of Quetiapine 3rd intermediate (chloro-ethyl thiazepine) was applied on the test site in pure state in a single dose.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (examinations after the patch removal at 1, 24, 48, 72 hours )
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: a gauze patch bearing the test item loosely held in place by adhesive but not irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the treatment perion the rest of the test item was removed with body temperature water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU