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Diss Factsheets
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EC number: 443-940-0 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- From Jun. 24, 2002 to Aug. 14, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD Guideline 471, EPA OPPTS 870.5100, EU Method B.13/14. and Japanese Substance Control Law (JSCL) Test Guideline III.1 in compliance with GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Japanese Substance Control Law (JSCL) Test Guideline III.1
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467
Constituent 1
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Plate incorporation test:
a: without metabolic activation:
50, 160, 500, 1600 and 5000 µg/plate
b: with metabolic activation:
50,160, 500, 1600 and 5000 µg /plate
Preincubation test:
a: without metabolic activation:
50, 160, 500, 1600 and 5000 µg/plate
b: with metabolic activation:
50, 160, 500, 1600 and 5000 µg /plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Soluble in DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- sodium azide
- Remarks:
- None
Migrated to IUCLID6: (for strain TA 100 and TA 1535)
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- 9-aminoacridine
- Remarks:
- None
Migrated to IUCLID6: (for strain TA 1537)
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- None
Migrated to IUCLID6: (for strain TA 98)
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (without metabolic activation)
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- None
Migrated to IUCLID6: (for strain WP2uvrA)
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (with metabolic activation-10 % rat liver)
- Positive control substance:
- other: 2-aminoanthracene for all strains
- Remarks:
- None
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (with metabolic activation-30 % Syrian golden hamster liver and preincubation)
- Positive control substance:
- other: 2-aminoanthracene for strain TA 100, TA 1535, TA 1537 and WP2uvrA
- Remarks:
- None
- Untreated negative controls:
- yes
- Remarks:
- (untreated control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- (with metabolic activation-30 % Syrian golden hamster liver and preincubation)
- Positive control substance:
- congo red
- Remarks:
- None
Migrated to IUCLID6: (for strain TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Incubation period: 48 h at approx. 37 °C
NUMBER OF REPLICATIONS: Three
DETERMINATION OF CYTOTOXICITY
- Method: A reduction in the number of spontaneously occurring colonies and visible thinning of the bacterial lawn were used as toxicity indicators.
Thinning of the bacterial lawn was evaluated microscopically. - Evaluation criteria:
- The test substance was considered positive if
(a) at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
(b) a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
If the test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system - Statistics:
- Not reported (According to the OECD guideline 471, a statistical analysis of the data was not mandatory).
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 applicable
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance did not precipitate on the plates up to the highest investigated dose of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, the test substance is not mutagenic in the absence and presence of exogenous metabolic activation in the standard plate incorporation and the preincubation tests. - Executive summary:
A study was conducted to determine the mutagenic potential of test substance according to OECD Guideline 471, EPA OPPTS 870.5100, EU method B.13/14.and Japanese Substance Control Law (JSCL) Test Guideline III.1 in compliance with GLP.
Strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA were used in the mutagenicity assay.
Two independent mutagenicity studies were conducted, one as the standard plate test with the plate incorporation method and the other as a modified preincubation test (Prival test). The studies were performed in the absence and in the presence of a metabolizing system derived from a rat liver homogenate or a hamster liver homogenate. For both studies, the compound was dissolved in deionized water, and each bacterial strain was exposed to 5 dose levels.
Doses for both studies ranged from 50 to 5000µg/plate.
Control plates without mutagen showed that the number of spontaneous revertant colonies was within the laboratory's historical control range. All the positive control compounds gave the expected increase in the number of revertant colonies.
In the preincubation test the number of revertant colonies of the solvent controls in the presence of
S9-mix and the number of revertants colonies of the positive controls in the absence of S9-mix
with the strain WP2uvrA were out of the historical control data range, but the criteria for the
negative/positive responses were fulfilled.
Toxicity: In the mutagenicity experiments toxicity was not observed either with or without metabolic activation.
Plate incorporation test: Both in the absence and in the presence of rat liver(10 % (v/v)) metabolic activation system the test substance did not result in relevant increases in the number of revertants in any of the bacterial strains.
In the absence and in the presence of hamster liver S9-mix (30 % (v/v)) using the preincubation method according to Prival, test substance did not result in relevant increases in the number of revertant colonies with any of the tester strains.
Under the test conditions, the test substance is not mutagenic in the absence and presence of exogenous metabolic activation in the standard plate incorporation and the preincubation tests.
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.
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