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EC number: 620-069-6 | CAS number: 945553-94-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005 - 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and according to an OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 7-(benzenesulfonyl)-N-(3-chloro-4-fluorophenyl)-6-nitroquinazolin-4-amine
- EC Number:
- 620-069-6
- Cas Number:
- 945553-94-6
- Molecular formula:
- C20 H12 Cl F N4 O4 S
- IUPAC Name:
- 7-(benzenesulfonyl)-N-(3-chloro-4-fluorophenyl)-6-nitroquinazolin-4-amine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: BIBW 2992 Sulfon (intermediate of BIBW 2992 MA2)
Appearance: yellow - crystalline powder
Batch number: V12SRE00198
Purity: 99.7 area % (HPLC, method: AF10_LC3_BIBWSulfon_LM_MS)
Certificate of analysis: dated 13 June 2005
Stability: confirmed until May 2006 (to be retested)
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach/Riss, Germany
Storage conditions: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species, number of animals: 9 rats, 3 males (M) and 6 females (F)
- Strain: Crl: WI(Han), SPF quality
- Supplier/Source: Charles River Deutschland GmbH, Sulzfeld, Germany via Biological Laboratory Services, Boehringer Ingelheim Pharma GmbH & Co. KG
- Age (Day 1): approximately 8 weeks
- Body weight range at study initiation (Day 1): males 207 g-221 g, females 130 g-148 g
- Housing: a barrier-protected system under standardized air conditions (They were kept in groups of up to three animals of one gender per cage (Noryl, type V))
- Diet (e.g. ad libitum): pelleted dry food (Kliba No. 3438.9.25, Provimi Kliba SA, Kaiseraugst, Switzerland) ad libitum
- Water (e.g. ad libitum): municipal tap drinking water (Stadtwerke Biberach) ad libitum via drinking bottles
- Acclimation period: 5- to 8-day pretest period
ENVIRONMENTAL CONDITIONS
- Room number: 35, building N81
- Temperature (°C): 22 +/- 2
- Relative Humidity (%): 45 - 75
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12:12 hrs, illumination period: 6:00 - 18:00, average illumination: approximately 60 lx (depending on the cage position; during work in the room the intensity is raised to approximately 450 lx)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX)
- Details on oral exposure:
- Directly before administration, the appropriate amount of test item was weighed into a tared glass beaker, was brought to volume with vehicle and was thoroughly mixed using an Ultra-Turrax homogenizer.
VEHICLE
- Test: Concentration: 200 and 2000 mg/kg test item per kg bw were mixed in 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX).
- Amount of vehicle (if gavage): 20 mL/kg in each group
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw - Doses:
- 200 and 2000 mg/kg bw
single dose, 20 ml/kg bw - No. of animals per sex per dose:
- 3 female animals at 200 mg/kg
3 per sex at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of weighing: 24 h after arrival, prior to first application (day -1) and on day 1, 2, 8 and 15
- Frequency of clinical observations: twice a day on the working days and once a day per non-working day
- Necropsy of survivors performed: yes (gross pathology)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In rats, no mortality was observed subsequent to a single oral administration of 200 mg/kg and 2000 mg/kg, respectively.
- Clinical signs:
- other: dose: 200 mg/kg (3 females) - Piloerection was seen at Day 1 (1 to 6 h post administration). All females returned to normal at Day 1 (8.0 h p.a.). - No further clinical signs were recorded. dose: 2000 mg/kg (males and females) - No clinical signs were no
- Gross pathology:
- No necropsy findings were noted in females treated with 200 mg/kg, as well as in rats of both genders subsequent to administration of 2000 mg/kg.
- Other findings:
- Clinical signs during the study were restricted to females which showed piloerection at both dose levels up to 6 h post administration.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality was seen in rats subsequent to oral administration of 200 mg/kg or 2000 mg/kg BIBW 2992 Sulfon.
Thus, the approximate lethal dose (ALD) for BIBW 2992 Sulfon, an intermediate of BIBW 2992 MA2, is set above 2000 mg/kg.
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