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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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Micromethod Ames's test
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Avena Sativa leaf/stem extract
- IUPAC Name:
- Avena Sativa leaf/stem extract
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- The test substance is a dry extract containing maltodextrine. This compound is not expected to interfere with the results of the test as it is an inert substance.
Method
- Target gene:
- His locus
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA1537, TA98, TA100
- Details on mammalian cell type (if applicable):
- rfa mutation for all strains; pKM 101 ampicillin resistance plasmid for strains TA100 and TA 98
- Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of rat liver
- Test concentrations with justification for top dose:
- 0.29, 0.86, 2.57, 7.72, 23.15, 69.44, 208.33, 625, 1250, 2500 µg/plate
Solubility was the limiting factor for maximum dose. - Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-anthramine
- Details on test system and experimental conditions:
- Incubation during 48h.
Each dose is performed in triplicate, per strain and type of treatment. - Rationale for test conditions:
- Reference to the guideline study
- Evaluation criteria:
- Mean number of spontaneous revertants per plate
- Statistics:
- Yes, method not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- 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 1537
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- significant increase of revertants at 69.04 µg/plate but induction ratio of 3 was not reached
- 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 100
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Remarks:
- increase in revertants at 625 to 2500 µg/plate but induction ratio of 2 not reached
- 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 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- significant increase in revertants at 2500 µg/plate but induction ratio of 2 not reached
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Validity criteria were fulfilled.
Results on TA100, without metabolic activation at the three highest doses: statistically significant increase in the mean number of revertants in presence of test item. But induction ratio of 2 was not reached and the mean number of revertants were within the limits of historical data for negative control in the same experimental conditions. However, taking into account the absence of toxicity of test item at the doses tested, the clear dose-response relationship obseved and the fact that the maximum tested dose was limited by the solubility of test item, results were considered equivocal. To confirm or invalidate the mutagenicity of test item in this strain, an additional assay under the same experimental conditions but using a narrower range of doses (e.g. 3000-2500-2000-1500-1000-750-500-250) should be undertaken. - Remarks on result:
- other: no biologically significant
- Remarks:
- No dose-response relationship
Applicant's summary and conclusion
- Conclusions:
- The test item S02542 provided by Institut de Recherche Pierre Fabre induced an equivocal result on Salmonella typhimurium strain TA100, in absence of metabolic activation, in a screening micromethod assay of the Ames's test without repetition.
In return, no mutagenic activity was observed in the Salmonella typhimurium strains TA1537 and TA98 in absence or in presence of metabolic activation system, or in strain TA100 in presence of metabolic activation.
An additional assay should be performed, under the same experimental conditions, in strain TA100 in absence of metabolic activation, using a narrower dose range between 3000 and 250 µg/mL.
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