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EC number: 432-070-7 | 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:
- May 1998 - July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD 471
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- none
Constituent 1
Method
- Target gene:
- Strains TA 98, TA 100, TA 1535, TA 1537 were used.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The nutrient medium contained 15 g per litre nutrient broth (SIFIN GmbH, Berlin)
- Properly maintained: yes
- Periodically checked for histidine dependence
- Periodically checked for cell membrane permeability
- Periodically checked for ampicillin resistance - Additional strain / cell type characteristics:
- other: hisD3052, rfa, uvrB, pKM101
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The nutrient medium contained 15 g per litre nutrient broth (SIFIN GmbH, Berlin)
- Properly maintained: yes
- Periodically checked for histidine dependence
- Periodically checked for cell membrane permeability
- Periodically checked for ampicillin resistance - Additional strain / cell type characteristics:
- other: hisG46, rfa, uvrB, pKM101
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The nutrient medium contained 15 g per litre nutrient broth (SIFIN GmbH, Berlin)
- Properly maintained: yes
- Periodically checked for histidine dependence
- Periodically checked for cell membrane permeability
- Periodically checked for ampicillin resistance - Additional strain / cell type characteristics:
- other: HisG46, uvrB, rfa
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- - Type and identity of media: The nutrient medium contained 15 g per litre nutrient broth (SIFIN GmbH, Berlin)
- Properly maintained: yes
- Periodically checked for histidine dependence
- Periodically checked for cell membrane permeability
- Periodically checked for ampicillin resistance - Additional strain / cell type characteristics:
- other: hisC3076, rfa, uvrB
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 metabolic activation
- Test concentrations with justification for top dose:
- Experiment I:
Concentration range (with metabolic activation/with S9): 0.05, 0.1, 0.5, 1.0, and 5.0 mg/plate Concentration range (without metabolic activation/without S9): 0.05, 0.1, 0.5, 1.0, and 5.0 mg/plate
Experiment II:
Concentration range (with metabolic activation/with S9): 0.05, 0.1, 0.5, 1.0, and 5.0 mg/plate
Concentration range (without metabolic activation/without S9): 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation system (without S9 mix) Migrated to IUCLID6: TA 1535 and TA 100
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation system (without S9 mix) Migrated to IUCLID6: TA 1537
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation system (without S9 mix) Migrated to IUCLID6: TA 98
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- TA 1535, TA 100, TA 1537, TA 98
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation (with S9 mix)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
The test substance was tested at five concentration levels of 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate.
The following were added to sterile disposable tubes containing 2 ml of top agar:
- 0.1 ml test article dilution or
- 0.1 ml of solvent (negative control) or
- 0.1 ml positive control solution
- 0.1 ml of appropriate bacterial culture
- 0.5 ml of S9 mix or 0.5 ml of 0.2 M phosphate buffer
The contents of each tube were mixed and added to a Petri dish containing minimal agar.
When the top agar had set, the Petri dishes were inverted and incubated at +3 7°C for 48 hours.
Revertant colonies were scored manually at the end of the incubation period.
NUMBER OF REPLICATIONS:
Each test variant was performed as threefold replicate.
OTHER:
All used bacterial strains are defective in DNA-repair (L\uvrB). The strains also have a defective lipopolysaccharide barrier on the cell wall (rfa). These properties confer extra sensitivity to DNA damage and also greater permeability to large molecules. The strains TA 98 and TA 100 also contain a plasmid (pKM101) which enhances the effor prone repair and confers ampicillin resistance. The strains are routinely tested for histidine dependence, cell membrane permeability and ampicillin resistance. - Evaluation criteria:
- POSITIVE RESULT:
A test is considered to be positive if the test article induces dose related increases in numbers of revertants scored in two separate experiments and these increases are deemed to be of biological relevance. Reproducible increases at one experimental point may also indicate a positive response. For a biologically relevant response the number of revertants is expected to be at least double the spontaneous reversion rate in the S. typhimurium strains TA 98, TA 100. In the S. typhimurium strains TA 1535 and TA 1537 the number ofrevertants is expected to be at least the tripie of the spontaneous reversion rate.
NEGATIVE RESULT:
A test article producing neither a dose related and reproducible increase in the number of revertants nor a reproducible positive response at any experimental point is considered to be non-mutagenic in this test system. - Statistics:
- STATISTICAL METHDODS USED:
The results are presented as individual plate counts. In addition mean values and standard deviations are calculated for each strain and experimental point.
PARAMETERS THAT WERE ANALYSED:
- dose related increase in revertant numbers (with and without S9 metabolic activation)
- reproducible increase at a single experimental point (with and without S9 metabolic activation)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.05, 0.1, 0.5, 1.0, 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.05, 0.1, 0.5, 1.0, 5.0 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
The revertant frequencies of the vehicle control were within the expected range and the positive control chemieals induced marked increases in revertant colonies. No biologically relevant increases in revertant numbers were obtained after treatment with Brüggolit FF6 in any bacterial strain and at any concentration tested. This applies to both, the presence and absence of metabolie activation.
See attached PDF-File "1998_07_03_02_FF6_Reverse Mutation Test_Results" (Table 2 -5)
TEST-SPECIFIC CONFOUNDING FACTORS:
none
RANGE-FINDING/SCREENING STUDIES:
The response of the untreated tester strains and the responses of the tester strains to the vehicle control, the test article at specified concentrations and the positive controls are shown in the attached PDF-File "1998_07_03_02_FF6_Reverse Mutation Test_Results" (Table 1).
At the chosen concentrations (5.0 to 0.01 mg/plate) no influence was observed to the number of spontaneous revertants and to the bacterial
backround lawn.
COMPARISON WITH HISTORICAL CONTROL DATA: In both independet experiments controls gave counts of spontaneous revertants within the normalranges obtained in this laboratory. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Toxicity rangefinder (preleminary test)
Any other information on results incl. tables
Main experiment:
The responses of the untreated tester strains and the responses of the tester strains to the vehicle control, the test article at specified concentrations and the positive controls are presented in Tables 2 to 5 (two independent experiments without and with metabolic activation). All vehicle controls gave counts of spontaneous revertants within the expected ranges.
The positive controls markedly increased the number of revertant colonies in all bacterial strains with and without metabolie activation. No increase in revertant numbers which might indicate a mutagenic response was observed at any concentration of the test article and in any bacterial strain.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
the test item is considered to ben non-mutagenic in the bacterial reverse mutation test. - Executive summary:
The test item was tested for a possible potential to induee gene mutation in bacteria.
As test organisms the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 were used. The bacteria were exposed to the test item both, in the presence and absence of rat Iiver 89 metabolic activation. Two independent experiments were performed according to the standard plate incorporation method.
Toxicity Rangefinder: At the chosen concentrations of 5.0 to 0.01 mg/plate no influence was observed to the number of spontaneaous revertants and to the bacterial background lawn. Based on these results concentrations of 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate were chosen for the mutation experiment.
Mutation Experiment: No increase in revertant numbers which might indicate a mutagenic response was observed at
any concentration of the test article and in any bacterial strain. After treatment with the test article neither a dose related increase in revertant numbers nor a reproducible increase at a single experimental point was observed for any bacterial strain
tested. This applies to both, the presence and absence of rat liver S9 metabolic activation.
Based on the results of the reported study it is concluded that the test item does not induce gene mutation in Salmonella typhimurium under the experimental conditions described. Therefore, the test item is considered to be non-mutagenic in the bacterial reverse mutation test.
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