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EC number: 428-290-8 | CAS number: 120606-08-8
- 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)
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 2010.
Test material
- Reference substance name:
- Benzyl-N-(2-(2-methoxy-phenoxy)-ethyl)amine hydrochloride
- EC Number:
- 428-290-8
- EC Name:
- Benzyl-N-(2-(2-methoxy-phenoxy)-ethyl)amine hydrochloride
- Cas Number:
- 120606-08-8
- Molecular formula:
- C16H20ClNO2
- IUPAC Name:
- benzyl[2-(2-methoxyphenoxy)ethyl]amine hydrochloride
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Carvedilol 6th/a intermediate (BEG HCl = Benzylaminoethoxy-guaiacol hydrochloride)
- Physical state: white or almost white crystalline powder
- Lot/batch No.: S-3082/1
- Expiration date of the lot/batch: 02. 2002
- Storage condition of test material: dry and cool place
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: 339-388 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 mlAscorbic acid
- Acclimation period: 14 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)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1 % methylcellulose
- Concentration / amount:
- 10 (w/v) % (test item in methyl cellulose (1%) for dermal treatment
5 (w/v) % (test item in methyl cellulose (1%) for challange treatment
0.1 % (in physiological saline and Freund's complete adjuvant ) for intradermal treatment
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1 % methylcellulose
- Concentration / amount:
- 10 (w/v) % (test item in methyl cellulose (1%) for dermal treatment
5 (w/v) % (test item in methyl cellulose (1%) for challange treatment
0.1 % (in physiological saline and Freund's complete adjuvant ) for intradermal treatment
- No. of animals per dose:
- 2 animals/two concentrations (in one animals two concentrations were tested: one concentration in left side, and other concentrations in right side)
10 animals (in test groups)
5 animals (in control groups) - Details on study design:
- RANGE FINDING TESTS:
Two dose levels were tested in the preliminari dose range finding study to specify the primary irritation by intradermal injection and three dose levels by dermal application. (0.1, 1 w/v % and 1, 5, 10 w/v %)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: I. a row of three injections , six in all, on each side of animals twice (test and control animals)
II. a row of dermal treatment on the same animals after seven days
- Exposure period: II. 48 hours
- Test groups: 10 animals
- Control group: 5 animals
- Frequency of applications: dermal treatment: six days after injections; untreated 14 days prior to challenge
- Duration: 48 hours +14 days
- Concentrations: 0.1% and 10%
B. CHALLENGE EXPOSURE (performed as a dermal exposure - close patch test)
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Concentrations: 5 %
- Evaluation (hr after challenge): 24 and 48 hours
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- patchy, confluent erythema
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- patchy, confluent erythema
Any other information on results incl. tables
Positive response was observed in 10% of the test animlas after the challenge with the test item. At the same time, positive response in the control group could not be found.
Challenge with the test item elicited discrete erythema in one animal on the skin surface of previously sensitized guinea pigs. The mean of the score was 0.10 and 0.00 according to the 24th and 48th hour observations.
The observed skin reaction in case of one animal may be attributed to the primary irritation of the test item and the individual sensitivity of the animal.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the results of the present study, the test item was classified as no sensitizer.
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