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EC number: 276-017-4 | CAS number: 71786-67-9
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Benzyl(3-hydroxyphenacyl)methylammonium chloride
- EC Number:
- 276-017-4
- EC Name:
- Benzyl(3-hydroxyphenacyl)methylammonium chloride
- Cas Number:
- 71786-67-9
- Molecular formula:
- C16H17NO2.ClH
- IUPAC Name:
- benzyl(3-hydroxyphenacyl)methylammonium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Benzyladrianon HCl
- Physical state: solid
- Analytical purity: 99.07 %
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River, Sulzfeld, Germany
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 28.9 - 34.5 g
- Assigned to test groups randomly: yes, under following basis: as they came to hand from delivery boxes
- Housing: Group Housing of 5 animals per sex per cage in labeled polycarbonate cages containing purified sawdust bedding material.
- Diet (e.g. ad libitum): Free access to standart pelleted laboratory animal diet ( Altromin )
- Water (e.g. ad libitum):Free access to tap water
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12:12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Concentration of test material in vehicle: 150 mg/kg BW
- Type and concentration of dispersant aid (if powder): 1:1 (w:v) - Details on exposure:
- dosing volume : 10 mL/kg body weight
- Frequency of treatment:
- single dosing
- Post exposure period:
- 24 h or 48 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150 mg/kg BW
Basis:
nominal conc.
- No. of animals per sex per dose:
- 2 male animals for the range finding test
10 male animals per dose ( 5 male animals per sampling time ) - Control animals:
- yes
- Positive control(s):
- cyclophosphamide dissolved in saline
- Route of administration: intraperitoneal injection
- Doses / concentrations: 50 mg sat/kg BW
Examinations
- Tissues and cell types examined:
- bone marrow
erythrocytes - Evaluation criteria:
- A test substance is considered positive in the micronucleus test if it induced a biologically as well as statistically significant ( Wilcoxon Rank Sum
Test; two-sided test at P < 0.05 ) increase in the ferquency of micronucleated polychromatic erythrocytes.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- see: Any other Information
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Within one hour after dosing all animals showed ataxia and were agressive, two animals also showed tremor and one animal also showed tremor and convulsion. Within 20 hours and 44 hours after dosing all animals showed no abnormalities.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concludet that this test is valid and that Benzyladrianon HCl is not mutagenic in the micronucleus test under the experimental conditions described in this report. - Executive summary:
Benzyldarianon HCl was tested in the Micronucleus test in mice to evalute its genotoxic effect on erythrocytes in bone marrow.
Two groups each comprising 5 males received an interperitoneal injection of 150 mg/kg body weight. After dosing the animals of the
treatment group showed following toxic signs: ataxia, convulsation, tremor and agression.
A vehicle treated group ( 1 % ( w/v) carboxymethylcellulose ) served as negative control, a group trated with a single intraperitoneal injection of cyclophosphamide at 50 mg/kg body weight served as positive control.
Bone marrow of the groups treated with Benzyladrianon HCl was sampled 24 and 48 hours after dosing. Bone marrow from the negative control group was harvested 24 hours after dosing and bone marrow from the positive control group was harvestedat 48 hours after dosing only.
Cyclophosphamide, the positive control substance, induced a statistically significant increase in the number of micronucleated polychromatic erythrocytes.
No biologically significant increase in the frequency of micro nucleated polychromatic erythrocytes was observed in the polychromatic erytrocytes of the bone marrow of animals treated with Benzyladrianon HCl.
The groups that wer treated with Benzyladrianon HCl showed no decrease in the ratio of polycrhomatic to normochromatic erythrocytes compared to the vehicle controls, which reflects a lack of toxic effects of this compound on the erythropoiesis. The groups that were treated with cyclophosphamide showed a decrease in the ratio of polycrhomatic to normochromatic erythrocytes compared to the vehicle controls.
It is concludet that this test is valid and that Benzyladrianon HCl is not mutagenic in the micronucleus test under the experimental conditions described in this report.
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