Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
acute toxicity upon intraperitoneal application
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
EC Number:
277-823-9
EC Name:
3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
Cas Number:
74336-59-7
Molecular formula:
C17H11ClN6O3
IUPAC Name:
3-[(4-chloro-2-nitrophenyl)diazenyl]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one
Details on test material:
- Name of test material (as cited in study report): Pigmentorange Kan 78/1775
- Test substance number: 80/404
- Physical state: solid, orange
- Analytical purity: > 98 %
- Lot/batch No.: Batch 8

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: about 4 weeks
- Mean weight at study initiation: 22 g (males), 20 g (females)
- Fasting period before study: 16 hours before administration, but water is available ad libitum.
- Housing: 5 per cage, Type IV Makrolon cages
- Diet: Herilan, mouse/rat/hamster maintenance diet; H. Eggersmann KG, Rinteln, Germany; ad libitum
- Water: Demineralized water each workday, tap water on holidays; ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous carboxymethyl cellulose
Details on exposure:
VEHICLE
- Concentration in vehicle: 20 % in 0.5% aqueous carboxymethyl cellulose
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
- Form of administration: Suspension

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs < 15, 15 and 30 minutes, 1 h, 2 h, 4 h and 5 h after administration of test substance and then once each workday. Check for moribund and dead animals twice each workday and once on weekends and public holidays.
- Frequency of weighing: Animals of comparable weights (± 10 g) in one cage. Group weighing before administration, 2nd weighing on days 2 - 4, 3rd weighing on day 7, 4th weighing on day 13 after administration.
- Necropsy of survivors performed: yes, withdrawal of feed 16 hours before sacrifice with CO2 then necropsy with gross-pathological
assessment. All animals that died are necropsied as early as possible.
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality.
Mortality:
No mortality observed (0/10 animals).
Clinical signs:
Males and females: Dyspnea, apathy, staggering, stretching, ruffled fur and poor general state 5 hours after treatment up to 2 days
Body weight:
No abnormalities in body weight gain detected.
mean body weight:
- day 0: males: 22 g, females: 20 g;
- day 2-4: males: 23.6 g, females: 21 g;
- day 7: males: 27.0 g, females: 25.0 g;
- day 13: males: 28.4 g, females: 26.4 g.
Gross pathology:
Intra-abdominal incorporations of test substance in sacrificed animals detected.
Other findings:
No other findings.

Applicant's summary and conclusion