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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-092-5 | CAS number: 115-46-8
- 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
Germ cell mutagenicity
In the study performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) Azacyclonol is not mutagenic either in the absence or in the presence of an exogenous metabolizing system.
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:
- other information
- Study period:
- January 21 to March 06 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD, GLP study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- solid - liquid: suspension
- Name of test material (as cited in study report): 4-Piperidine Diphenyl Methanol (Azacyclonol) Base
- Physical state: white grain powder
- Analytical purity: 98.3 % (w/w)
- Lot/batch No.: 86000298
- Date of expiry: September 10, 1998
- Storage condition of test material: darkness at approximately 5 °C in refrigerator, protected from light
- Soluble and stable in DMSO. - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Strains are deficient in the structure of their lipopolysaccharide layer and in DNA excision repair system. TA 98 and TA 100 also possess a modified postreplication DNA repair system which frequently causes an increase in the rate of mutations.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- First mutation experiment:
With and without metabolic activation: 4, 20, 100, 500, 2500 and 5000 µg/plate
Second mutation experiment:
With and without metabolic activation: 0.8, 4, 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Remarks:
- Solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 and TA 100 without S-9
- Untreated negative controls:
- yes
- Remarks:
- Solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S-9
- Untreated negative controls:
- yes
- Remarks:
- Solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without S-9
- Untreated negative controls:
- yes
- Remarks:
- Solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA1535, TA 1537, TA 100 and TA 98 with S-9
- Details on test system and experimental conditions:
- A toxicity test using histidine-enriched agar plates and a dilution of the tester strain TA 100 (designated TA 100 D) was performed in parallel with the second mutation experiment.
- Evaluation criteria:
- Criteria for a valid assay:
The assay is considered valid if the following criteria are met:
- the solvent control data are within the laboratory's normal control range for the spontaneous mutant frequency.
- the positive controls induced increases in the mutation frequency which were bath statistically significant and within the laboratory's normal range.
Criteria for a positive response:
A test compound is classified as mutagenic if it has either of the following effects:
a) it produces 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) it induces 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.
The test results must be reproducible. - Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Strain-dependent toxicity was observed in a dose range of 2500 to 5000 µg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Strain-dependent toxicity was observed in a dose range of 500 to 2500 µg/plate and above without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
The test compound proved to be toxic to the bacterial strain TA 100 D in the presence and in the absence of metabolic activation at concentration of 2500 µg/plate.
Only in the first experiment an increased number of revertants was found in the tester strain TA 1537 in the absence of S9 -mix, but this effect was caused by the law spontaneous mutation frequency of the corresponding solvent control and therefore considered to be without biological relevance.- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results
negative - Executive summary:
Azacyclonol is not mutagenic in these bacterial test systems either in the absence or in the presence of an exogenous metabolizing system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Germ cell mutagenicity
In the study performed according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) Azacyclonol is not mutagenic either in the absence or in the presence of an exogenous metabolizing system. Overall, the substance is not classified for this property.
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.