10-[4-(2-chloroethyl)piperazin-1-yl]-2-thia-9-azatricyclo[9.4.0.0³,⁸]pentadeca-1(11),3(8),4,6,9,12,14-heptaene

Skin irritation / corrosion

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

Test material information

Constituent 1

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