Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye 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 405 (Acute Eye Irritation / Corrosion)
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: cream-coloured crystalline powder
- Lot/batch No.: 2001/1
- Expiration date of the lot/batch: April 2002
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder: Ferenc Sándor, Address: Vörös Hadsereg 131, H-2173 Kartal, Hungary
- Age at study initiation: adult (11 weeks)
- Weight at study initiation: 2660-3118 g
at study termination: 2737-3299 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, UNIPLUS standard diet for rabbits produced by AGRIBANDS Europe
- Water (e.g. ad libitum): ad libitum, tap water for human consumption from automatic self-supplying watering system
- Acclimation period: 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of test item Quetiapine 3rd intermediate (chloro-ethyl thiazepine) in pure state in a single dose
Duration of treatment / exposure:
The eyes of the test animals were not washed out after the application of the test item.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
The eyes of the test animals were not washed out after the application of the test item.

SCORING SYSTEM:
Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 25.33
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 2.66
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, the test item applied to the rabbit eye mucosa proved to be irritant. The observed symptoms can be evaluted as fully reversible alterations.