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EC number: 200-090-3 | CAS number: 51-34-3
- 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 / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 March 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The read-across justification is included as attachmant to Iuclid section 13.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- publication
- Title:
- Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: Evalutions of 108 chemicals.
- Author:
- Galloway, S. M. et al.
- Year:
- 1 987
- Bibliographic source:
- Environ. Mol. Mutagen. 10 (Suppl. 10), 1-175
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Hyoscine hydrobromide trihydrate
- Cas Number:
- 6533-68-2
- Molecular formula:
- C17 H21 N O4 . Br H . 3 H2 O
- IUPAC Name:
- Hyoscine hydrobromide trihydrate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Analytical purity: 102%+-0.6% (functional group titration)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- -S9: 1000, 1600, 3000 µg/mL
+S9: 1600, 3000, 5000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- DURATION
- Exposure duration:
- without S9: treatment time 10.5 hr; when after the addition of Colcemid: incubation time 2 hr
- with S9: treatment time 2 hr; when change of medium; incubation time 11 to 11.5 hr with Colcemid present in the final 2 hr
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): GiemsaIn the aberration test without S9, cells were incubated in McCoy's 5A medium with scopolamine hydrobromide trihydrate for 10.5 hours; Colcemid was added and incubation continued for 2 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa. For the Aberration with S9, cells were treated with scopolamine hydrobromide trihydrate and S9 for 2 hours, after which the treatment medium was removed and the cells were incubated for 11 to 11.5 hours in fresh medium, with Colcemid present for the final 2 hours. Cells were harvested in the same manner as for the treatment without S9. As an alteration in pH was observed in the first trial conducted with S9 and the second trial with S9 was conducted with HEPES buffer present in the medium to stabilize pH.
NUMBER OF CELLS EVALUATED: 200 first-division metaphase cells were scored at each dose level - Statistics:
- To arrive at a statistical call for a trial, analyses were conducted on both the dose response curve and individual dose points. For a single trial, a statistically significant (P<=0.05) difference for one dose point and a significant trend (P<=0.015) were considered weak evidence for a positive response; significant differences for two or more doses indicated the trial was positive. A positive trend test in the absence of a statistically significant increase at any one dose resulted in an equivocal call.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- the high dose was limited by toxicity in the trials conducted without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- with S9, no toxicity was noted and 5 mg/mL was selected as the high dose
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Induction of Chromosomal Aberration in Chinese Hamster Ovary Cells by Scopolaminehydrobromide Trihydrate
Dose (µg/mL) | Total Cells | No. of Abs | Abs/Cell | Cells with Abs (%) | Dose (µg/mL) | Total Cells | No. of Abs | Abs/Cell | Cell with Abs (%) | ||
-S9 | +S9 | ||||||||||
DMSO | 200 | 2 | 0.01 | 1.0 | DMSO | 200 | 1 | 0.01 | 0.5 | ||
Mitomycin C | 0.0625 | 200 | 40 | 0.20 | 16.0 | Cyclo- phosphamide | 2.5 | 200 | 35 | 0.18 | 15.0 |
0.2500 | 50 | 17 | 0.34 | 30.0 | 7.5 | 50 | 23 | 0.46 | 36.0 | ||
Scopolamine-hydrobromidetrihydrate | 1000 | 200 | 1 | 0.01 | 0.5 | Scopolamine-hydrobromidetrihydrate(Trial 1) | 1600 | 200 | 3 | 0.02 | 1.5 |
1600 | 200 | 2 | 0.01 | 1.0 | 3000 | 200 | 2 | 0.01 | 1.0 | ||
3000 | 200 | 1 | 0.01 | 0.5 | 5000 | 200 | 12 | 0.06 | 6.0 | ||
P=0.655 | P<0.001 | ||||||||||
(Trial 2) DMSO | 200 | 1 | 0.01 | 0.5 | |||||||
Cyclophosphamide | 2.5 | 200 | 28 | 0.14 | 12.0 | ||||||
7.5 | 50 | 17 | 0.34 | 34 | |||||||
Scopolamine-hydrobromide trihydrate (Trial 2) | 1600 | 200 | 3 | 0.02 | 1.5 | ||||||
3000 | 200 | 2 | 0.01 | 1.0 | |||||||
5000 | 200 | 28 | 0.14 | 11.0 | |||||||
P<0.001 |
Applicant's summary and conclusion
- Conclusions:
- Positive with metabolic activation. Induction of chromosome aberration was observed in cultured CHO cells in the presence of S9 metabolic activation in each of two trials at the highest dose tested (5000 µg/mL).
- Executive summary:
The present study determined the mutagenicity of Scopolamine hydrobomide trihydrate according to a well-described method which is similar to a current internationally established guidelines (OECD 473). The effects were analysed using the Chinese hamster ovary cells with or without S9 mix (from Sprague Dawley rat liver). The study was part of the National Toxicology Program (NTP) of the U.S. Department of Health and Human Services and reviewed and showed that the test item has mutagenic properties under conditions of metabolic activation.
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