Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 277-823-9 | CAS number: 74336-59-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (mostly due to reduced reporting in times before GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The application volume was not calculated by the individual weight, but by the mean weight per sex
- Principles of method if other than guideline:
- Standardized test method (BASF-Test)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- 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 12 weeks
- Mean weight at study initiation: males 170 g, females 180 g
- Fasting period before study: 16 hours
- Housing: 5 animals per cage; Type DK-Ill stainless steel wire mesh cages (Becker & Co., Castrop-Rauxel, Germany)
- Diet: Herilan, mouse/rat/hamster maintenance diet; H. Eggersmann KG, Rinteln, Germany, ad libitum
- Water: Fully demineralized water each workday ad libitum; on holidays tap water ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % aqueous carboxymethyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 31.6 % (w/v)
- Amount of vehicle (if gavage): 2.69 mL/male; 2.84 mL/female
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: 15.8 mL/kg bw
DOSAGE PREPARATION (if unusual):
- Form of administration: Suspension - Doses:
- 5000 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:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality.
- Mortality:
- No mortality detected (0/10 animals).
- Clinical signs:
- other: No abnormalities detected.
- Gross pathology:
- No abnormalities in sacrificed animals detected.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
