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EC number: 480-420-2 | CAS number: 144702-27-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC, EPA guidelines, see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 480-420-2
- EC Name:
- -
- Cas Number:
- 144702-27-2
- Molecular formula:
- C33 H29 N5
- IUPAC Name:
- 4'-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}-[1,1'-biphenyl]-2-carbonitrile
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): BIBR 277 Nitril
- Physical state: solid
- Analytical purity: 99.7 %
- Purity test date: 17 October 2005
- Lot/batch No.: T02/03
- Expiration date of the lot/batch: April 2006
- Storage condition of test material: at room temperature , dark and dry
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: LAB-ALL, Bt. Budapest, 1174 Hunyadi u. 7.
- Weight at study initiation: 313-349 g
- Housing: al animals were housed in Macrolon cages, size III, with 2-3 animals per cage.
- Diet (e.g. ad libitum): PURISTAR standard diet for rabbit ad libitum
- Water (e.g. ad libitum): tap water ad libitum, with 50 mg/100 mL ascorbic acid.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70% (relative humidity)
- Air changes (per hr): 8-12 per hour by central air-condition system
- Photoperiod (hrs dark / hrs light): 12 hours light daily from 6 am - 6pm (artificial light).
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- BIBR 277 Nitril was formulated in methyl cellulose (1%). the mixture was stirred using a magnetic stirrer before and during the treatment
For intra-dermal exposure test: BIBR 277 Nitril was adminstrated at concentrations of 0.1%
For dermal induction: BIBR 277 Nitril was applied at concentrations of 75%
For the challenge exposure: BIBR 277 Nitril was applied at concentrations of 50% in vehicle (methyl cellulose (1% ))
Control animals were treated with vehicle methyl cellulose ( 1%)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methyl cellulose (1%)
- Concentration / amount:
- BIBR 277 Nitril was formulated in methyl cellulose (1%). the mixture was stirred using a magnetic stirrer before and during the treatment
For intra-dermal exposure test: BIBR 277 Nitril was adminstrated at concentrations of 0.1%
For dermal induction: BIBR 277 Nitril was applied at concentrations of 75%
For the challenge exposure: BIBR 277 Nitril was applied at concentrations of 50% in vehicle (methyl cellulose (1% ))
Control animals were treated with vehicle methyl cellulose ( 1%)
- No. of animals per dose:
- 10 test animals, 5 control animals per test.
- Details on study design:
- RANGE FINDING TESTS: a preliminary dose-finding study was performed
Test item was applied at concentrations of 0.01 and 0.1 % (w/v) for intra-dermal injection and 10, 25, 50 and 75% (w/v) for dermal application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 injections per animal for intra-dermal induction test, 1 per animal for dermal induction test.
- Exposure period: 24h (intradermal), 48h (epicutaneous)
-day(s) of challenge: day 8 after first induction test
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
- Evaluation (hr after challenge): 24 or intra-dermal induction test and 1, 24, 48 and 72 hours after exposure
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: day 22 after first induction test
- Exposure period: 24 hours
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
- Evaluation (hr after challenge): 24 and 48 hrs after exposure - Challenge controls:
- Challenge controls were treated with the test substance at c=50%.
- Positive control substance(s):
- yes
- Remarks:
- Reliability studies are carried out twice a year, using items that are known to have moderate skin sensitisation properties. Latest check: 16 feb-12 March 2012 . Results are available.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- none
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: none. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75% . No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Challenge with the test item BIBR 277 Nitril caused no signs of sensitisation in test animals previously sensitised. At the same time, none of the control animals showed signs of skin sensitisation. The net response value was thus 0%, as no indications for adverse skin reactions were noted.
The test item was classified as a non-senisitiser, based on this guinea pig test and according to current EU-regulations.
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