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EC number: 607-988-8 | CAS number: 2668-75-9
- 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:
- November to December 1996
- 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:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- no E. coli WP2 or S. typhimurium TA102 strain tested.
- Principles of method if other than guideline:
- Direct plate incorporation procedure was performed. No E. coli WP2 or S. typhimurium TA102 strain tested; no preincubation test performed. These requirements were first formulated in the adoption of the guideline in 1997 and thus the study was conducted prior to implementation of these requirements.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
- EC Number:
- 607-988-8
- Cas Number:
- 2668-75-9
- Molecular formula:
- C23 H28 O4
- IUPAC Name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- 0.10, 0.25, 0.50, 1.00, 2.50 and 5.0 mg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine (9-AA, only TA 1537), 2-nitrofluorene (2-NF, only TA 1538 and 98), sodium azide (NaN3, only TA 1538 and 100), benzo(a)pyrene (BP, only TA 100 and 98), cyclophosphamide (CP, only TA 1535), 2-aminoanthracene (2-AA, all strains)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: one
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition - Evaluation criteria:
- The plates were scored for the number of mutant colonies with an automated colony counter (Artek M 982B, Artek Systems Corporation, Farmingdale, NY, USA). The arithmetic means of the number of mutant colonies of the 3 parallel plates in the negative control groups were compared with those of the compound groups. A positive response was considered if at least 5 mg/plate or up to a toxic dose had been tested (or the compound formed precipitates in the agar) and if the number of induced revertants compared to the number of spontaneous ones was reproducibly higher than 2-fold. A dose-dependent increase in the number of revertants was also considered to indicate a mutagenic effect.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 1.0 mg/ plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
- Genotoxicity:
None of the tester strains showed an increase in mutant counts with the substance at the concentrations tested, either in the absence or presence of S9 mix.
- Cytotoxicity:
Growth inhibition of the background lawn was observed in all strains tested from 1.0 mg/plate onwards in the absence of S9 mix and at the highest dose tested with S9 mix.
- Precipitation:
Precipitates in the agar were found starting from 2.5 mg/plate onwards in all strains tested without and with S9 mix.
Applicant's summary and conclusion
- Conclusions:
- No increase of reverse gene mutations in bacteria induced by the test item up to maximum concentration of 1.0 mg/ plate without S9 and 5 mg/ plate with S9 mix.
- Executive summary:
The substance was examined for mutagenic activity in the Ames Salmonella/microsome test with the five histidine-dependent Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98, all with and without metabolic activation. E. coli WP2 or S. typhimurium TA102 strains were not investigated. The test substance concentration ranged from 0.1 to 5.0 mg/plate.
Growth inhibition of the background lawn was observed in all strains tested from 1.0 mg/plate onwards in the absence of S9 mix and at the highest dose tested with S9 mix. Precipitates in the agar were found starting from 2.5 mg/plate onwards in all strains tested without and with S9 mix. None of the tester strains showed an increase in mutant counts with the substance at the concentrations tested, either in the absence or presence of S9 mix. It was therefore concluded, that the substance is not a mutagen in the specified test.
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