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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.