Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003 - 2006
- 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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- The following deviations from the standardized study plan occurred which were considered to have no impact on the integrity of the study:
- Deviations from the specified range for relative humidity (45 – 75 %) were observed intermittently: for short periods of time during cleaning in the morning, relative humidity rose up to approximately 95 %.
- Due to their high body weight, food for rabbits was restricted to 120 g per day per animal (instead of ad libitum feeding). - GLP compliance:
- 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 in the chemical synthesis 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: guaranteed until May 2006
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
Storage conditions: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 3 female rabbits, strain: Chbb:NZW (New Zealand White)
- Age (day of application): approximately 9 – 10 months
- Body weight (day of application): 4.0 – 4.7 kg
- Supplier/Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG
- Housing: individually in solid wire cages
- Diet (e.g. ad libitum): dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland) was restricted to 120 g per animal and day
- Water (e.g. ad libitum): municipal drinking water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Room number: housing and application in room 40 (building N81)
- Temperature (°C): 22 +/- 2
- 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)
Test system
- Type of coverage:
- other: occluded by muslin tissue and fixed by a non-skin-irritating plaster
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site/rabbit - Duration of treatment / exposure:
- pretest period
- one animal was treated initially
- sequentiall exposure on three skin areas of about 6 cm2 for 3 min, 1 hr and 4 hr (Application to the next skin area was only performed in the absence of serious skin alterations in the previous one.)
- at the end of the exposure, residual test item was removed by using demineralized water
main test
- 4 hours
- at the end of the exposure, residual test item was removed by using demineralized water - Observation period:
- immediately after the end of exposure, 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6cm²
- % coverage: 100
- Type of wrap if used: muslin tissue / non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with demineralized water
- Time after start of exposure: 4 hrs
SCORING SYSTEM: as described in OECD 404 guideline
- general appearance of the rabbits was inspected twice daily
- The animals were killed at the end of study with an intravenous overdose of ketamine / xylazine.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all
- Time point:
- other: all time points up to 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: all
- Time point:
- other: all time points up to 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- none
Any other information on results incl. tables
In summary, BIBW 2992 Sulfon had no irritating or corrosive effect on rabbit skin subsequent to dermal application.
No alterations of the rabbits' general appearance were observed subsequent to local application of the test item. In addition, no skin reaction beyond the area of exposure was observed.
Application of BIBW 2992 Sulfon did not result in any effect on body weight development.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin alterations beyond the area of exposure.
The test item was determined to be not irritating.
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.