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Diss Factsheets
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EC number: 202-715-5 | CAS number: 98-94-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Adequacy of study:
- other information
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: Expert Statement
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The purpose of the study was to determien the potential of toxicokinetic effects of the test substance based on its physico-chemical information.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexyldimethylamine
- EC Number:
- 202-715-5
- EC Name:
- Cyclohexyldimethylamine
- Cas Number:
- 98-94-2
- Molecular formula:
- C8H17N
- IUPAC Name:
- N,N-dimethylcyclohexanamine
- Reference substance name:
- N,N-dimethylcyclohexanamine
- Cas Number:
- 98-94-2
- IUPAC Name:
- N,N-dimethylcyclohexanamine
- Details on test material:
- - Name of test material (as cited in study report): DMCHA
- Molecular weight (if other than submission substance): 127
- Physical state: Liquid
- Boiling point (°C): 135-160
- Relative density: 0.85-0.89
- Vapour pressure: circa 440Pa at 26°C; 3.17 hPa at 21.5°C
- Water solubility: circa 1% at 20°C or 13.4 g/L
- Partition coefficient: log Kow 2.01 at 25°C
- Viscosity: 2.8 cST
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- no
Test animals
- Species:
- other: Not relevant
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not relevant
Administration / exposure
- Route of administration:
- other: Not relevant
- Vehicle:
- not specified
- Details on exposure:
- Not relevant
- Duration and frequency of treatment / exposure:
- Not relevant
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not relevant
- No. of animals per sex per dose / concentration:
- Not relevant
- Control animals:
- not specified
- Positive control reference chemical:
- Not relevant
- Details on study design:
- In order to determine any toxicokinetic or toxicodynamic responses, the physico-chemical properties and toxicity responses were evaluated, in the absence of any specific study reports addressing metabolism, toxicokinetics or other ADME responses. The Toxicokinetic phase begins with exposure and results in a certain concentration of the ultimate toxicant at the target site (tissue dose). This concentration is dependent on the absorption, distribution, metabolism and excretion (ADME) of the substance. ADME describes the uptake of a substance into the body, its lifecycle within the body, and ultimately elimination via excretion:
ABSORPTION: how, how much, and how fast the substance enters the body;
DISTRIBUTION: reversible transfer of substances between various parts of the organism, i.e. body fluids or tissues;
METABOLISM: the enzymatic or non-enzymatic transformation of the substance of interest into a structurally different chemical (metabolite);
EXCRETION: the physical loss of the parent substance and/or its metabolite(s); the principal routes of excretion are via the urine, bile (faeces), and exhaled air.
Metabolism and excretion are the two components of ELIMINATION, which describe the loss of substance by the organism, either by physical departure or by chemical transformation.
DISPOSITION: The sum of processes following absorption of a chemical into the circulatory systems, distribution throughout the body, biotransformation, and excretion. - Details on dosing and sampling:
- The moderate water solubility (13.4 g/L) of cyclohexyldimethylamine (DMCHA) was considered favourable for facilitating absorption within the gastro-intestinal tract. Another major route for toxicants to enter the body would be via lung absorption. The low LC50 value for acute inhalation toxicity indicates ready absorption through pulmonary membranes. The log Kow of 2.31 indicates that there is potential for DMCHA absorption across biological membranes and also for passive diffusion, supporting the apparent systemic absorption resulting in relatively high toxicity by oral and inhalation routes. It is not feasible to quantify absorption based on the available data, but the indications are that DMCHA is readily absorbable. Based on this information, it can be envisaged that once absorbed, DMCHA will be distributed throughout the body, across biological membranes such as the gastro-intestinal membrane and the membranes of the respiratory system.
- Statistics:
- Not relevant
Results and discussion
- Preliminary studies:
- No information provided
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- DMCHA is absorbed via oral, dermal and inhalation routes of exposure.
- Details on distribution in tissues:
- No information provided
- Details on excretion:
- No information provided
Metabolite characterisation studies
- Details on metabolites:
- No information provided
Any other information on results incl. tables
The moderate water solubility (13.4 g/L) of cyclohexyldimethylamine (DMCHA) was considered favourable for facilitating absorption within the gastro-intestinal tract. Another major route for toxicants to enter the body would be via lung absorption. The low LC50 value for acute inhalation toxicity indicates ready absorption through pulmonary membranes. The log Kow of 2.31 indicates that there is potential for DMCHA absorption across biological membranes and also for passive diffusion, supporting the apparent systemic absorption resulting in relatively high toxicity by oral and inhalation routes. It is not feasible to quantify absorption based on the available data, but the indications are that DMCHA is readily absorbable. Based on this information, it can be envisaged that once absorbed, DMCHA will be distributed throughout the body, across biological membranes such as the gastro-intestinal membrane and the membranes of the respiratory system.
The small molecular weight of the test substance (127g/mol) and Log Kow values do not satisfy the criteria set out in the guidance for indicating reduced dermal absorption, in fact the observed physiological changes following topical application indicate that mechanical bypassing of the dermis is feasible by corrosive action and tissue damage and that systemic exposure is likely following dermal exposure – the dermal LD50 is relatively low in two species (<400 mg//kg bw) indicating that dermal absorption is occurring. Given the similarity of median lethal doses following oral or dermal administration it is feasible to assume that dermal absorption approximates to the oral absorption value and a value of 100% should be considered for risk assessment purposes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no data
The substance is likely to be bioavailable following oral, dermal and inhalation exposure. - Executive summary:
A theoretical assessment of the likely toxicokinetics of the substance is performed based on its physicochemical properties and limited toxicological data. The data indicate that the substance is likely to be bioavailable following oral, dermal and inhalation exposure. Simple comparison of the acute oral and dermal toxicity of the substance indicates that dermal absorption is likely to be extensive. The water solubility of the substance favours extensive and even systemic distribution via the circulatory system. QSAR indicates extensive metabolism; the production of a number of highly water-soluble metabolites favours urinary excretion and indicates that bioaccumulation is unlikely. In addition to this, the OECD Toolbox shows that the molecules satisfies Lipinski’s rule of 5, indicating it is likely to be bioavailable, and predicts a total of 15 hepatic metabolites resulting from N-dealkylation, N-oxidation and ring hydroxylation reactions.
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.
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