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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-168-8 | CAS number: 1761-71-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.04.1982- 31.08.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study performed according to standard Ames testing guidelines with no major deviations (minor deviations: the test substance was tested up to very slight toxicity, no more than 27% toxicity in strain TA98 (without S9-mix) and 2-aminoanthracene alone is insufficient as a positive control with S9).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 79/831/EEC
- Deviations:
- yes
- Remarks:
- : 2-aminoanthracene alone is insufficient as a positive control with S9
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-methylenebis(cyclohexylamine)
- EC Number:
- 217-168-8
- EC Name:
- 4,4'-methylenebis(cyclohexylamine)
- Cas Number:
- 1761-71-3
- Molecular formula:
- C13H26N2
- IUPAC Name:
- 4,4'-methylenedicyclohexanamine
- Details on test material:
- - Name of test material (as cited in study report): cyclohexyl,4,4'-methylenebis-
- Analytical purity: no data ("rein")
Constituent 1
Method
- Target gene:
- histidine locus
Species / strain
- Species / strain / cell type:
- other: S.typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Clophen A 50 induced rat liver
- Test concentrations with justification for top dose:
- - Dosing: 4, 12.5, 40, 125, 400 ug/plate
- Additional experiment: 125, 400, 800 ug/plate - Vehicle / solvent:
- - Vehicle/solvent used: ethanol (70%)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : 70% ethanol
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine for TA1537, sodium azide for TA100 and TA1535, 2-nitrofluorene for TA98 and TA1538
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- : 70% ethanol
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene for all strains
- Remarks:
- with S9
- Details on test system and experimental conditions:
- PLATE INCORPORATION TEST
The following components were mixed in a sterile tube:
-2 mL top-agar
-0,1 mL of the bacterial overnight culture (0,8- 1,5x 10^8 bacteria/ mL)
-0,01 mL of the test item or solvent
-0,5 mL S9 mix
The mixing was done in triplicate for each bacterial strain and for each concentration of the test material and the mixture was then poured onto the surface of minimal agar plates.
-Incubation: 72 hours, 37 °C and then the number of revertant colonies was counted - Rationale for test conditions:
- The toxicity of the test item was tested with and without metabolic activation. Doses from 62,5 µg - 2000 µg/ plate were tested. As the highest test dose 800 µg/ plate were chosen (survival of 10-15 % without and 70 % with metabolic activation)
- Evaluation criteria:
- CRITERIA FOR EVALUATING RESULTS:
- Dose related increase in the number of revertant colonies - Statistics:
- not applicable
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 800 ug/plate
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- GENOTOXIC EFFECTS:
- With metabolic activation: negative
- Without metabolic activation: negative,
TA1538 additional experiment; 3-fold increase. However, in one experiment only.
PRECIPITATION CONCENTRATION:
- no precipitate
CYTOTOXIC CONCENTRATION:
- With metabolic activation: very slight toxicity at 800 ug/plate
- Without metabolic activation: very slight toxicity at 800 ug/plate
STATISTICAL RESULTS:
- not applicable
Applicant's summary and conclusion
- Conclusions:
- An Ames-test was performed to assess the mutagenis properties of the test item. The test item was proven to be non mutagenic in the absence and presence of S9 mix.
- Executive summary:
The test item was tested for its ability to induce reverse mutations in an in vitro bacterial system. Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were treated with the test compound by the Ames test plate incorporation. Dose levels up to 800 µg/ plate, in triplicate both with and without the addition of metabolising system were employed.
All bacterial strains exhibited mutagenis responses to the appropriate positive control substances. Solvent controls were also tested with each strain and the mean numbers of spontaneous revertants were in an acceptable range.
A reproducible mutagenic activity of the test compound to any of the tester strains was not observed with and without metabolic activation.
It is therefore concluded, that the test item is not a bacterial mutagen.
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.