Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
![](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:
- 2012-01-13 to 2012-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- His
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- experiment I: rat S9 liver microsomal fraction; experiment II: hamster S9 liver microsomal fraction
- Test concentrations with justification for top dose:
- Experiment I and II:
31.6, 100, 316, 1000, 2500 and 5000 µg/plate
A third (confirmatory) experiment was performed with tester strain TA 100 (without metabolic activation) with the following concentrations:
31.6, 100, 316, 1000, 1750, 2500, 3750 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: A.dest.
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest., BSL Lot No. 111219, 120105, 120203, 120305
- Negative solvent / vehicle controls:
- yes
- Remarks:
- A. dest., BSL Lot No. 111219, 120105, 120203, 120305
- Positive controls:
- yes
- Positive control substance:
- other: see remarks
- Remarks:
- Without metabolic activation: sodium azide (tester strains TA100, TA1535); 4-nitro-o-phenylene-diamine (TA98, TA1537); methylmethanesulfonate (TA102). With metabolic activation: 2-aminoanthracene for all strains; exception: TA 98, hamster liver: congored
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 min; 100 µL of the test item preparation was pre-incubated with the tester strains (100 µL) and sterile buffer or the metabolic activation system (500 µL) for 30 min at 30 °C prior to adding the overlay agar (2000 µL) and pouring onto the surface of a minimal agar plate.
- Exposure duration: at least 48 h; After solidification the plates were inverted and incubated at 37 °C for at least 48 h in the dark.
NUMBER OF REPLICATIONS: For each strain and dose level, including the controls, three plates were used (in a one case only two plates were evaluated).
DETERMINATION OF CYTOTOXICITY
- Method: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- experiment II, TA 102
- Additional information on results:
- No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No biologically relevant increases in revertant colony numbers were noted in tester strains TA 98, TA 1535, TA 1537 and TA 102 (with and without metabolic activation) and in tester strain TA 100 with metabolic activation.
An increase of revertant colony numbers was observed in tester strain TA 100 at concentrations of 2500 µg/plate and higher (without metabolic activation, only experiment I). A maximum mutation factor of 2.0 was reached at a concentration of 2500 µg/plate (without metabolic activation). A dose-response relationship was found.
In the confirmatory experiment (experiment III) these findings could not be verified. All colony number were within the historical data range, no increased mutation factors have been observed. Therefore, the increase of revertant colony numbers in experiment I was considered to be not biologically relevant.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, FAT 40858/A TE did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, FAT 40858/A TE is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
In a reverse gene mutation assay in bacteria - modified for azo compounds-, strains TA98, TA100, TA1535, TA1537 and TA102 of S. typhimurium were exposed to FAT 40858/A TE at concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate (experiment I and II) and 31.6, 100, 316, 1000, 1750, 2500, 3750 and 5000 µg/plate (experiment III), in the presence and absence of mammalian metabolic activation according to the plate incorporation method with rat liver S9 (experiment I and III) and the pre-incubation method with hamster liver S9 (experiment II).
FAT 40858/A TE was tested up to the limit concentration of 5000 µg/plate in all tester strains used.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5100; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Die ECHA bietet zahlreiches Online-Material in Ihrer Sprache an, ein Teil dieser Seite liegt jedoch nur auf Englisch vor. Mehr über die Praxis der Mehrsprachigkeit bei der ECHA.
Willkommen auf der Website der ECHA! Unsere Website wird von Internet Explorer 7 (und älteren Versionen) nicht uneingeschränkt unterstützt. Bitte verwenden Sie Internet Explorer in einer neueren Version.
Damit Sie die Website optimal nutzen können, verwenden wir Cookies.
Weitere Informationen über unsere Verwendung von Cookies.