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EC number: 470-870-8 | CAS number: 690271-93-3
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18th August 2004 - 31st August 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Terracess TF
- IUPAC Name:
- Terracess TF
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Terracess TF-L
- Appearance: white powder
- Purity: 99.6%
- Lot/batch No.: 26472 (laboratory identification number)
Constituent 1
Method
- Target gene:
- histidine locus (salmonella)
tyryptophan locus (Ecoli)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Tester strain cultures were checked for the following genetic markers on the day of the preparation of master plates.
The histidine requirement was tested by comparing the growth of each Salmonella tester strain on a histidine/biotin-supplemented minimum glucose agar plate with their growth on a biotin-only minimum glucose agar plate.
The tryptophan requirement was tested by comparing the growth of WP2uvrA strain on a tryptophan-supplemented minimum glucose agar plate with their growth on a minimum glucose agar plate.
For the Salmonella tester strains the presence of the rfa wall mutation was confirmed by demonstration of the sensitivity of the cultures to crystal violet.
The presence of uvrA and uvrB mutation was demonstrated by their sensitivity to ultraviolet light of the tester strains.
The presence of the pKM101 plasmid was confirmed for cultures of tester strains TA98 and TA 100 by demonstration of resistance to ampicillin.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver (S-9 mix).
- Test concentrations with justification for top dose:
- Initial toxicity mutation test: 33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 µg per plate.
Confirmatory mutagenicity test: 333, 667, 1000, 3333, and 5000 µg per plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (dimethyl sulfoxide)
- Justification for choice of solvent/vehicle: DMSO was chosen as the dosing vehicle based on the solubility of the test substance and compatibility with the target cells. Terracess TF-L was a homogeneous suspension in DMSO at the highest concentration, 50 mg/ml, tested in the study.
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Others used: benzo[a]pyrene 2-nitrofluorene; 2-arninoanthracene; sodium azide and ICR-191
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 667 µg/plate
- Evaluation criteria:
- Strains TA1535 and TA1537: Data will be judged positive if the increase in mean revertants at the highest numerical dose response is ? 3.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response
associated with increasing concentrations of the test substance.
2. Strains TA98, TAl00 and WP2uvrA: Data sets will be judged positive if the increase in mean revertants at the highest numerical dose
response is ? 2.0-fold the mean concurrent negative control value (vehicle control). This increase in the mean number of revertants per plate must be accompanied by a dose response to increasing concentrations of the test substance. - Statistics:
- For each tester strain, the mean of the number of revertants and the standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- 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
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- 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
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- 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
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No appreciable toxicity was observed in any of the tester
strains.
No positive mutagenic responses were observed in any of the tester strains at any dose level in either the presence or absence of the metabolic activation.
Any other information on results incl. tables
The S9 was thawed and the 10% S9 mix prepared immediately prior to its use. The S9 mix was held on ice at all times before use. The S9 mix contained the following components:
dd-H20 |
2.4 mL |
0.825 M KCI/0.2 M MgCl2 |
0.4 mL |
0.2 M phosphate buffer, pH 7.4 |
5.0 mL |
10 mL |
0.2 mL |
0.04MNADP |
l.0 mL |
S9 |
l.0 mL |
Total Volume |
10 mL |
No contaminant colonies were observed on the sterility plates for the most concentrated test substance dilution (50 mg/mL) and the S9 and sham mixes (100 mM phosphate buffer at pH 7.4)
Applicant's summary and conclusion
- Conclusions:
- All criteria for a valid study were met. Under the conditions of this study, Terracess TF-L showed no evidence of mutagenicity in the Bacterial Reverse Mutation Test either in the presence or absence of Aroclor-induced rat liver S9. The test substance was concluded to be negative in this study.
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