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EC number: 610-764-2 | CAS number: 51997-51-4
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The studies were carried out in 2002.
Test material
- Reference substance name:
- 4-[(oxiran-2-yl)methoxy]-9H-carbazole
- EC Number:
- 610-764-2
- Cas Number:
- 51997-51-4
- Molecular formula:
- C15H13NO2
- IUPAC Name:
- 4-[(oxiran-2-yl)methoxy]-9H-carbazole
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Carvedilol 4th intermediate (Oxiranylmethoxy carbazole)
- Physical state: chamois powder
- Lot/batch No.: 2002/2
- Expiration date of the lot/batch: 02. 2002
- Storage condition of test material: dry and cool place, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt , Hunyadi street 7, Budapest, H-1174, Hungary
- Weight at study initiation: 320-344 g
- Housing: Macrolon cage, size III (42x42x19 cm), 2-3 animals / cage
- Bedding: Laboratory bedding
- Diet (e.g. ad libitum): ad libitum (PURISTAR standard diet for rabbits produced by AGRIBANDS Europe Hungary)
- Water (e.g. ad libitum): ad libitum, tap water for human consumption containing 50 mg / 100 ml Ascorbic acid
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1% Methylcellulose
- Concentration / amount:
- 50 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment
0.1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment - Day(s)/duration:
- 2
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% Methylcellulose
- Concentration / amount:
- 50 (w/v) % (test item in methyl cellulose (1%) for dermal and challange treatment
0.1 % (in physiological saline and Freund's complete adjuvant for intradermal treatment - Day(s)/duration:
- 2
- No. of animals per dose:
- 2 animals/two concentrations (in one animal two cincentrations were tested: one concentration in left side, and other concentration in right side) in the range finding study.
10 animals (in test groups)
5 animals (in control groups) - Details on study design:
- RANGE FINDING TESTS:
2 dose levels were tested in the preliminari dose range finding study to specify the primary irritationby intradermal injection and dermal application. Two dose levels were tested in the preliminary dose range finding study to specify the primary irritation by intradermal injection and two dose levels by dermal application.
Further information about treatments see under paragraph 'any other information...' - Challenge controls:
- 5 control guinea pigs were simultaneously exposed to vehicle during the sensitization phase and they were treated with the test item ( at concentration of 10%) only in the case of challenge.
- Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema; moderate and confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- discrete or patchy erythema; moderate and confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Challenge with the test item elicited patchy and confluent erythema on the skin surface of previously sensitized guinea pigs. The mean of the scores was 0.9 and 0.6. The net scores was 0.5 and 0.4 according to the 24th and 48th hour observations.
In the control group the mean of the scores was 0.4 and 0.2.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information moderately Criteria used for interpretation of results: EU
- Conclusions:
- According to the net percentage value of positively responded animals and to the net score value of the skin reactions, the test item CARVEDILOL 4th INTERMEDIATE was classified as moderate sensitizer.
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