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EC number: 420-920-1 | CAS number: 128446-35-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD Guideline Study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Positive control (µg/plate): 1.0 (All Salmonella Strains), 10 (WP2 uvrA), 100 (WP2)
Positive control (µg/plate): 1.0 (TA98, TA1538), 1.0 (TA100, TA 1535), 75 (TA1537), 1,000 (Both E.coli Strains)
Vehicle (µg/plate): 6.5, 9.7, 32, 65, 97, 324, 648, 972, 3239, 4859
97mg/ml for 5mg/plate - Vehicle / solvent:
- - Solvent used: water
- Justification for choice of solvent: compatibility with the target cells
Test article was soluble in water at approximately 97 mg/ml, the maximum concentration tested. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- All Salmonella Strains and WP2 uvrA (pKM101) with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- WP2 (pKM101) without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1538 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Both E.coli Strains without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period:
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: other: dissecting microscope
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article. Data sets for strains TA1535, TA1537 and TA1538 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for strains TA98, TA100 and WP2 uvrA (pKM101) and WP2 (pKM101) were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value.
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: no
- Water solubility: Yes at approximately 97 mg/ml
- Precipitation:
- Other confounding effects: not applicable
RANGE-FINDING/SCREENING STUDIES: Yes
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, test article hydroxypropylated .beta.-cyclodextrin was concluded to be negative in the Salmonella/Mammalian Microsome (Ames Test) and Esclzericlzia coli WP2 Mutagenesis Assay. - Executive summary:
The test article, hydroxypropylated .beta.-cyclodextrin, was tested according to OECD Guideline 471 in the bacterial reverse mutation assay using S.typhimurium tester strains TA98, TA100, TA1535, TAl537 and TA1538 and E. coli tester strains WP2uvrA(pKM101) and WP2 (pKM101) in the presence and absence of Aroclor-induced rat liver S9. The assay was performed in two phases, using the plate incorporation and preincubation methods. The first phase, the dose range-finding study, was used to establish the dose range for the mutagenicity assay. The second phase, themutagenicity assay (initial and confirmatory assays), was used toevaluate the mutagenic potential of the test article. The preincubation method was used only for the confirmatory assay. The dosing solutions were adjusted to compensate for the purity of the test article.
Water was selected as the solvent of choice based on compatibility with the target cells. The test article was soluble in water at approximately 97 mg/ml, the maximum concentration tested.
In the preliminary toxicity assay, the maximum dose tested was 5 mg per plate; this dose was achieved using a concentration of 97 mg/ml and a 50 µl plating aliquot. Neither precipitate nor appreciable toxicity was observed. Based on the findings of the toxicity assay, the maximum dose plated in the mutagenicity assay was 5 mg per plate.
In the mutagenicity assay, no positive response was observed. Neither precipitate nor appreciable toxicity was observed.
Under the conditions of this study, test article hydroxypropylated .beta.-cyclodextrin was concluded to be negative in the Salmonella/Mammalian Microsome (Ames Test) and Esclzericlzia coli WP2 Mutagenesis Assay.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 79, 157, 313, 625, 1250, 2500, and 5000 µg/mL in non-activated and activated
- Vehicle / solvent:
- - Solvents used: Ham's F12 medium supplemented with 10% fetal bovine serum, 2mM L-glutamine, 100 units penicillin and 100 µg streptomycin/ml
- Justification for choice of solvent: solibility - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- S9 activated
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- S9 non-activated
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED: number and types of aberrations found are presented for each treatment flask
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- Prior to the analysis of the coded slides 50-100 cells from the solvent and positive control cultures were analyzed to determine that the percentage of aberrant cells in the solvent control \vas less than 6%, no cell had >2 aberrations and that the percentage of aberrant cells in the positive control was significantly increased relative to the solvent control.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: no
- Water solubility: not critical
- Precipitation: no
- Other confounding effects: none found
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: not available - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the findings of this study, hydroxypropylated .beta.-cyclodextrin was concluded to be negative for the induction of structural and numerical chromosome aberrations both in the presence and absence of S9 in Chinese hamster ovary (CHO) cells. - Executive summary:
The test article, hydroxypropylated .beta.-cyclodextrin , was tested according to OECD Guideline 473 in the chromosome aberration assay both in the absence and presence of metabolic activation (Aroclor-induced rat liver S9) using Chinese hamster ovary cells. The preliminary toxicity assay was conducted to establish the dose range for testing in the chromosome aberration assay. The chromosome aberration assay was conducted to evaluate the clastogenic potential of the test article. The test article dosing solutions were adjusted for the purity of the test article.
Culture medium (Ham's FI2 medium supplemented with 10% fetal bovine serum, 2mM L-glutamine, 100 units penicillin and 100 µg streptomycin/ml) was selected as the solvent of choice based on the solubility of the test article, information provided by the Sponsor and compatibility with the target cells. The test article was soluble in culture medium at approximately 500 mg/ml, the maximum concentration tested.
In the preliminary toxicity assay, the maximum dose level tested was 5000 µ/mL. The test article was soluble in treatment medium at all concentrations tested. No substantial toxicity, i.e., at least 50% cell growth inhibition, was observed at any of the doses tested regardless of exposure or harvest time. In the absence of substantial toxicity, the dose levels selected for testing in the chromosome aberration assay were 79, 157, 313, 625, 250, 2500, and 5000 µg/mL.
In the chromosome aberration assay, dose levels of 1250, 2500, and 5000 µg/mL were selected for microscopic analysis in both the non-activated and in the S9-activated test systems. Selection of doses for microscopic analysis was based on toxicity (the lowest dose with at least 50% reduction in cell growth and the next two lower doses) in all harvests.
Based on the findings of this study, hydroxypropylated .beta.-cyclodextrin was concluded to be negative for the induction of structural and numerical chromosome aberrations both in the presence and absence of S9 in Chinese hamster ovary (CHO) cells.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Structural similarity
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The substance is non mutagenic in mammalinan cells.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.