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EC number: 929-125-7 | CAS number: 1160293-25-3
- 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:
- 24 January - 4 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404) and in compliance with GLP.
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- PD 282 XX
- IUPAC Name:
- PD 282 XX
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): PD 282 XX
- Molecular weight (if other than submission substance): 267.67
- Physical state: rust-coloured crystals
- Analytical purity: 99.6 % (HPLC)
- Purity test date: 12 january 2006
- Lot/batch No.: V12SRE00325
- Expiration date of the lot/batch: stability confirmed until november 2006
- Storage condition of test material: 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
- Source: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG
- Age at study initiation: approximately 6 - 8 months
- Weight at study initiation: 3.8 – 4.2 kg (day of application)
- 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), ad libitum
- Water (e.g. ad libitum): municipal drinking water were supplied ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2°C
- Humidity (%): 45 - 75 %
- Air changes (per hr): approx. 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 h, with lights on from 6:00 h to 18:00 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- ca. 500 mg per animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hrs after exposure
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm², dorsal skin of the rabbit
- Type of wrap if used: muslin tissue, non-skin-irritating plaster
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h post application
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
PD 282 XX had no irritating or corrosive effect on rabbit skin subsequent to dermal application. The slight erythema observed 24 h after a 4 h exposure in one animal was reversible until 48 h post application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is non-irritating to skin according to EU classification.
- Executive summary:
The test item PD 282 XX is an intermediate in the chemical synthesis of BIBF 1120 ES, a
VEGFR-2 inhibitor intended for the treatment of cancer.
Based on current German law (Chemikaliengesetz [Chemicals Act], 20 June 2002, and
Gefahrstoffverordnung [Ordinance on Dangerous Substances], 23 December 2004), this
study was designed to evaluate the dermal tolerance of PD 282 XX subsequent to topical
application in rabbits. It was performed according to OECD Guideline 404 (Acute Dermal
Irritation/Corrosion, adopted 24 April 2002) and in accordance with the principles of Good
Laboratory Practice, as described by the respective OECD Guidelines and current German
law (Chemikaliengesetz).
A total of three female New Zealand White rabbits were exposed dermally to a paste of
approximately 0.5 g test item mixed with demineralized water. One female was treated at
three different sites for 3 min, 1 h, and 4 h, respectively, whereas the remaining two
females were exposed for 4 h on one site only. Skin reactions were recorded 1 h, as well as
24 h, 48 h, and 72 h following the end of exposure and graded. Further investigations
included recording of clinical signs and body weight.
Under the conditions of the present study, PD 282 XX was well tolerated subsequent to
topical application on rabbit skin. Slight erythema was observed in one out of three
females only, 24 h after a 4 h exposure of the test item PD 282 XX. This effect, however,
was reversible within 48 h post application. In addition, there were no signs of systemic
side effects or of skin alterations beyond the area of exposure.
Thus, according to the Globally Harmonized Hazard Classification and Labeling Scheme
(GHS), the test item PD 282 XX is not classified.
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.
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