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Diss Factsheets
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EC number: 942-166-5 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
One in vitro study on genetic toxicity in bacteria available. Nomcort SG was tested negative for mutagenicity.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study under GLP, only one experiment performed, but clearly negative result
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only one experiment performed
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine, Trypthophan
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat Liver S9 mix
- Test concentrations with justification for top dose:
- 0.05, 0.1, 0.5, 1.0, 5.0 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The test item was found to be completely soluble in the vehicle. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-Aminoanthracene, 6-Chloro-9-[3-(2-chloroethylamino)propylamino]-2-methoxyacridine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Exposure duration / Expression time): 48 h
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- according to Guideline (OECD 471)
- Statistics:
- calculation of Average and standard deviation, no further statistics performed
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- no further remarks
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
There was no detectable genotoxic activity or cytotoxicity for Nomcort SG under the conditions of the test. - Executive summary:
The genetic toxicity in bacteria was tested using the method by Ames laid down in OECD Guideline 471. Five strains of bacteria were tested (Salmonella typhimurium 98, 100, 1535, 1537 and Escherichia Coli WP2 uvrA) using a plate incorporation protocol. Nomcort SG was tested in the concentrations 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate with Acetone as solvent. Additionally positive and solvent control were tested. Metabolic activation was included using rat S9 -liver fraction.
All concentrations, positive and solvent control were tested in triplicate.
Solvent control and positive control were evaluated valid and within the historic data. No concentration of Nomcort SG with or without metabolic activation yielded in an increased mutagenic response, as well as no cytotoxicity was noted.
Nomcort SG was evaluated as NOT MUTAGENIC under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Justification for selection of genetic toxicity endpoint
Only one study available. This study is assessed as reliable and
usable.
Justification for classification or non-classification
The presented information is conclusive but not sufficient for classification.
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