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EC number: 202-854-1 | CAS number: 100-46-9
- 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 vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-06-04 to 2012-07-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals, July 22, 2010, Guideline No. 487 “In vitro Mammalian Cell Micronucleus Test.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Benzylamine
- EC Number:
- 202-854-1
- EC Name:
- Benzylamine
- Cas Number:
- 100-46-9
- Molecular formula:
- C7H9N
- IUPAC Name:
- 1-phenylmethanamine
- Test material form:
- other: Liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: About 5 x 10E5 cells per flask were seeded in 15 mL of MEM (minimal essential medium) containing Hank’s salts, glutamine, Hepes (25 mM) and 10 % (v/v) fetal bovine serum (FBS).
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for karyotype stability: Yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from phenobarbital/β-naphthoflavone treated rats
- Test concentrations with justification for top dose:
- Experiment I / II without S9-mix: 2.1, 4.2, 8.4, 16.8, 33.5, 67.0, 134.0, 268.0, 536.0, 1072.0 μg/mL
Experiment I with S9-mix: 2.1, 4.2, 8.4, 16.8, 33.5, 67.0, 134.0, 268.0, 536.0, 1072.0 μg/mL
Experiment II with S9-mix: 67.0, 134.0, 268.0, 536.0, 1072.0 μg/mL
In Experiment I in the absence and presence of S9 mix the pH was adjusted to physiological values at the highest applied concentration (1072.0 μg/mL) using small amounts of 2N HCl. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Deionised water
- Justification for choice of solvent/vehicle: Soluble in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Dissolved in deionised water; 0.3 μg/mL; without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: griseofulvin
- Remarks:
- Dissolved in DMSO; 8.0 μg/mL; continuous treatment; without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Dissolved in saline; 15 μg/mL; with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium
DURATION
- Exposure duration: Exp.I/II 4 hrs (with S9 mix); Exp.I 4hrs; Exp. II 24 hrs (wihout S9 mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 24 hrs
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 1000 cells
DETERMINATION OF CYTOTOXICITY
- Method: Cloning efficiency (proliferation index (PI) was calculated) - Evaluation criteria:
- Evaluation of Results
A test item can be classified as mutagenic if:
- the number of micronucleated cells is not in the range of the historical control data and
- either a statistically significant concentration-related increase in three test groups or a significant increase of micronucleated cells in at least one test group is observed.
A test item can be classified as non-mutagenic if:
- the number of micronucleated cells in all evaluated test groups is in the range of the historical control data and
- no statistically significant concentration-related increase in the number of micronucleated cells is observed. - Statistics:
- Statistical significance was confirmed by means of the Chi square test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In Experiment I in the absence and presence of S9 mix and in Experiment II in the presence of S9 mix no mutagenicity was observed up to the highest required concentration.
In Experiment II in the absence of S9 mix statistically significant increases (1.25, 2.28, 7.75 and 3.63 % micronucleated cells) were observed at all evaluated concentrations (134.0 - 1072.0 μg/mL). Since the three highest values clearly exceeded the historical control data range of 0.05 - 1.50 % micronucleated cells, Benzylamine is considered mutagenic.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH value was slightly increased at the highest applied concentration
- Effects of osmolarity: No
- Precipitation: No
COMPARISON WITH HISTORICAL CONTROL DATA:
Mitomycin C (0.3 μg/mL), Griseofulvin (8.0 μg/mL) and CPA (15 μg/mL) were used as positive controls and showed a distinct increase in the percentage of micronucleated cells.
The solvent control was deionised water (10 % v/v) saline and culture medium MEM.
Exp. I
Number of micronucleated cells: Without S9 mix: preparation interval 24 hrs, treatment 4 hrs
Solv. control (10.0 %): 0.35 – 1.50 %
Positive control MMC (0.03 – 0.1 μg/mL): 0.85 – 18.15 %
In test:
Solv. control (10.0 %): 0.65%
Positive control MMC ( 0.3 μg/mL): 6.15 %
Test item (268 -1072 μg/mL): 0.3 - 0.9 %
Number of micronucleated cells; With S9 mix: preparation interval 24 hrs, treatment 4 hrs
Solv. control (10.0 %): 0.15 – 1.70 %
Positive control CPA (2.5 – 25.0 μg/mL): 0.90 – 38.30 %
In test:
Solv. control (10.0 %): 0.9 %
Positive control CPA (15.0 μg/mL): 9.9 %
Test item (268 -1072 μg/mL): 0.75 - 1.15 %
Exp. II
Number of micronucleated cells: Without S9 mix: preparation interval 24 hrs, treatment 24 hrs
Solv. control (10.0 % ): 0.15 – 1.50 %
Positive control Griseofulvin (6.3 – 25.0 μg/mL): 2.50 – 31.70 %
In test:
Solv. control (10.0 %): 0.35 %
Positive control Griseofulvin (8.0 μg/mL): 5.2 %
Test item (134 - 1072 μg/mL): 1.25 -7.75 %
Number of micronucleated cells; With S9 mix: preparation interval 24 hrs, treatment 4 hrs
Solv. control (10.0 %): 0.15 – 1.70 %
Positive control CPA (2.5 – 25.0 μg/mL): 0.90 – 38.30 %
In test:
Solv. control (10.0 %): 0.95 %
Positive control CPA (15.0 μg/mL): 16.05 %
Test item (268 - 1072 μg/mL): 0.8 - 1.5 %
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the absence and presence of metabolic activation no cytotoxicity measured as reduced proliferation index was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
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