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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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