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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-516-4 | CAS number: 3129-92-8
- 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
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-June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- See remark below
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- See remark below
- Principles of method if other than guideline:
- Deviation: The protocol requires that the performance of the test be evaluated with positive controls for each tester strain used. Due to an oversight, 2-Aminoanthracene was not added to strain TA1535 in the plate incorporation method.
As a result, strain TA1535 using the plate incorporation method was repeated along with appropriate sterility control check plates. The data collected from the initial test is maintained in the raw data. There was no impact on the study as the test was repeated for the bacteria strain. - GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzoic acid, compound with cyclohexylamine (1:1)
- EC Number:
- 221-516-4
- EC Name:
- Benzoic acid, compound with cyclohexylamine (1:1)
- Cas Number:
- 3129-92-8
- Molecular formula:
- C7H6O2.C6H13N
- IUPAC Name:
- cyclohexanamine benzoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Composition: Cyclohexyamine Benzoate - 99.7%, CAS #3129-92-8
Physical Description: Off-white crystalline powder
pH: ~7 (5% aq solution)
Stability: Test substance was expected to be stable for the duration of testing.
Expiration Date: Not applicable
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (cofactor supplemented post-mitochondrial fraction)
- Test concentrations with justification for top dose:
- 0, 1.58, 5.0, 15.8, 50, 158, 500, 1580, 5000 μg/plate
5000 μg/plate was selected as the top dose as it is the OECD standard limit dose. - Vehicle / solvent:
- The test substance was found to be soluble in sterile water that was used as the vehicle.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: ICR 1919 Acridine, Daunomycin, 2 aminoanthracene
- Details on test system and experimental conditions:
- Fresh bacterial suspension cultures in nutrient broth were prepared so that they were in the late exponential phase of growth at the time of use (approximately 1 x 109 bacteria/mL). Bacterial
growth was evaluated by spectrophotometric optical density measurement.
The test substance was formulated as a solution in sterile water (0.0158, 0.05, 0.158, 0.5, 1.58, 5, 15.8 and 50 mg/mL) to provide corresponding dose levels of up to 5000 µg/plate. The solutions
were vortexed prior to use. - Evaluation criteria:
- The mean revertant colony counts for each strain treated with the vehicle should lie close to or within the expected range taking into account the laboratory historical control range and/or published values (Mortelmans & Zeiger, 2000; Gatehouse, 2012). The positive controls (with S9 where required) should produce substantial increases in revertant colony numbers with the appropriate bacterial strain.
- Statistics:
- Calculated means and standard deviations for all quantitative data collected.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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:
- 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 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 100
- 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:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- The mean revertant colony counts for each strain treated with the vehicle were close to or within the expected range, considering the laboratory historical control range and/or published values
(Mortelmans & Zeiger, 2000; Gatehouse, 2012). The positive control substances caused the expected substantial increases in revertant colony counts in both the absence and presence of S9
in each phase of the test confirming the sensitivity of the test and the activity of the S9 mix. Therefore, each phase of the test is considered valid.
There was no evidence of toxicity or precipitation present for any of the strains at the tested concentrations. Individual plate contamination was noted for strain TA1537 in the plate incorporation method at 158 µg/plate with S9. Contamination did not impact mutagenic evaluation.
For all strains, eight non-toxic doses were evaluated; therefore bacterial mutagenicity was adequately assessed.
Applicant's summary and conclusion
- Conclusions:
- An OECD 471compliant Bacterial Reverse Mutation (Ames) test was conducted with Cyclohexylamine Benzoate at levels of 1.58, 5.0, 15.8, 50, 158, 500, 1580, and 5000 µg/plate.
There was no concentration-related or substantial test substance related increases in the number of revertant colonies observed with strains TA1535, TA1537, TA98 , TA100 or E.coli WP2 uvrA in both the absence and presence of S9 using either the plate incorporation or the pre-incubation method.
Based on these findings and on the evaluation system used, Cyclohexylamine Benzoate did not elicit evidence of bacterial mutagenicity in the Ames assay.
Under the condotions of the test, cyclohexylamine was not mutagenic. - Executive summary:
An OECD 471 Bacterial Reverse Mutation (Ames) test was conducted with Cyclohexylamine Benzoate at levels of 1.58, 5.0, 15.8, 50, 158, 500, 1580, and 5000 µg/plate.
The main test was conducted using the plate incorporation method in both the absence and presence of metabolic activation (chemically-induced rat liver S9 mix). The results of the test were confirmed using a similar study design but employing the pre-incubation modification of the Ames test.
There was no evidence of toxicity or precipitation present for any of the strains at the tested concentrations. Individual plate contamination was noted for strain TA1537 in the plate incorporation method at 158 µg/plate with S9. Contamination did not impact mutageni evaluation.
For all strains, eight non-toxic doses were evaluated; therefore bacterial mutagenicity was adequately assessed.
There was no concentration-related or substantial test substance related increases in the number of revertant colonies observed with strains TA1535, TA1537, TA98 , TA100 or E.coli WP2 uvrA in both the absence and presence of S9 using either the plate incorporation or the pre-incubation method.
Based on these findings and on the evaluation system used, Cyclohexylamine Benzoate did not elicit evidence of bacterial mutagenicity in the Ames assay.
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.