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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 17, 2001-August 23, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been performed according to OECD and GLP principles. No concentration was tested without precipitate and the independent repeat has no modification of study parameters. These deviations are considered not to influence the reliability of the study.
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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- other: ICH on Harmonisation of Technical requirements for registration of Pharmaceuticals for Human Use (1996 and 1997)
- Principles of method if other than guideline:
- - There was no concentration of test substance without precipitate.
- The independent repeat has no modification of study parameters. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Physical state: dark blue solid
Method
- Target gene:
- Histidine gene in S. typhimurium
Tryptophan gene in E. Coli
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Preliminary test: 6.7, 10, 33, 67, 100, 333, 667, 1000 and 3333 µg/plate
First and second test: 15, 50, 150, 400, 1250 and 3750 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran (THF)
- Justification for choice of solvent/vehicle: based on the compatibility with the target cells and the solubility of the test article.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran (THF)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- pos. control for TA1537 -S9
Migrated to IUCLID6: diluted in dimethyl sulfoxide (DMSO) Conc. 75 µg/plate
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- pos. control for TA98 -S9
Migrated to IUCLID6: diluted in dimethyl sulfoxide (DMSO) Conc. 1 µg/plate
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- pos. control for TA100, TA1535 -S9
Migrated to IUCLID6: diluted in water Conc. 1 µg/plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, diluted in dimethyl sulfoxide (DMSO) Conc. 1 µg/plate for all Salmonella strains and Conc. 10 µg/plate for E. Coli strain.
- Remarks:
- pos. control for WP2 uvrA + S9 and all Salmonella strains + S9
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- pos. control for WP2 uvrA -S9
Migrated to IUCLID6: diluted in dimethyl sulfoxide (DMSO) Conc. 1000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hr
NUMBER OF REPLICATIONS: all dose levels and test article, vehicle controls and positive controls were plated in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: a reduction in the background lawn, reduction in revertant colonies
OTHER:precipitation of test substance - Evaluation criteria:
- The following crtiteria mus be met for the mutagenicity assay to be considered valid.
All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene. Cultures of tester strains TA98 and TA100 must demonstrate the presence of the pKM101 plasmid R-factor. All WP2uvrA cultures must demonstrate the deletion in the uvrA gene. All cultures must demonstrate the charcateristic mean number of spontaneous revertants in the vehicle controls as follows (inclusive): TA98, 10-50; TA100, 80-240; TA1535, 5-45; TA1537, 3-21; WP2uvrA, 10-60. To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10^9 cells/mL. The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels are required to evaluate assay data. A dose level is considered toxic if one or both of the following criteria are met:
1. a >50% reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count.
2. a reduction in the background lawn.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
- Water solubility: a dose level of 3750 µg/plate is the maximum dose level that can be achieved based on the solubility of the test article and the maximum plating aliquot that can be used with tetrahydrofuran.
- Precipitation: Precipitate was observed at 15 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
No toxicity and mutagenicity was observed up to concentrations of 3333 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, the test substance did not cause a positive mutagenic response in either the presence or absence of Aroclor-induced rat liver S9.
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