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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 283-829-2 | CAS number: 84731-70-4
- 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://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- other: Paper-based toxicokinetic assessment
- Adequacy of study:
- key study
- Study period:
- May 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetic assessment has been conducted for the substance, DEHCH (Di 2-ethylhexyl cyclohexane-1,4-dicarboxylate). Summaries of studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII, point 8.8 of REACH. The assessment of the likely toxicokinetic behaviour of the substance was provided to the extent that can be derived from the relevant available information at the time of the assessment. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2012).
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Sex:
- not specified
- Route of administration:
- other: Not applicable
- Vehicle:
- other: Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
- Remarks:
- Doses / Concentrations:
Not applicable - No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- not specified
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Statistics:
- Not applicable
- Preliminary studies:
- Not applicable
- Details on absorption:
- Absorption
Results of the repeated dose/reproductive screening study in rats showed evidence to support the gastric absorption of the test item (Dunster, 2010). The relatively small molecular size of the substance should also allow absorption through passive diffusion. This is supported by the lipophilic nature of the substance (log10 Pow 8.84, Jeong, 2009). This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. Limited absorption may also take place via the skin due to the relatively small molecular size. The low vapour pressure value (7.45 x 10-4 Pa at 50°C; Jeong, 2009) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure. - Details on distribution in tissues:
- Distribution
Systemic distribution is evident from the repeated dose/reproductive screening study (Dunster, 2010) as a result of the organ changes observed. The lack of evidence to suggest the test item is a skin sensitizer suggests that it does not bind to carrier proteins in the circulatory system (Bae, 2009 c). Once absorbed, the substance may potentially accumulate in the adipose tissue due to the high log octanol/water partition coefficient value (Log10 Pow 8.84, Jeong, 2009). - Details on excretion:
- Excretion
There is no evidence to indicate the route of excretion but poorly water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. As there is evidence of hepatic metabolism this does not, however, rule out urinary excretion. The main reason for xenobiotic metabolism is to render the product more water soluble thereby facilitating urinary excretion. Any test item that is not absorbed will be excreted in the faeces. - Metabolites identified:
- not measured
- Details on metabolites:
- Metabolism
The results of the repeated dose/reproductive screening study showed the evidence of an adaptive response in the liver and thyroids in rats (Dunster, 2010); which is normally associated with enhanced metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising systems (Kim, 2009 a; Kim, 2009 c). - Conclusions:
- The available information suggests that absorption of the test substance from the gastrointestinal tract can take place, primarily as a consequence of the high log octanol/ water coefficient of the test item. Some absorption may also take place via the skin. Once absorbed, enhanced metabolism may occur and the substance would result in accumulation in the adipose tissues. Biliary excretion may well be significant route for the substance.
Reference
The substance is a clear colourless liquid and the molecular weight is 396.6 g/mol. The low vapour pressure value (7.45 x 10-4Pa at 50°C; Jeong, 2009) shows that the substance is non volatile therefore inhalation is not a significant route of exposure. The substance has a high log octanol/water partition coefficient value (Log10Pow8.84 Jeong, 2009) and low water solubility (47 μg/L; Jeong, 2009).The available repeated dose/reproductive screening study showed evidence of absorption and metabolism but did not show any evidence of excretion (Dunster, 2010).
The test item is non-mutagenic in bacteria (Kim, 2009 c), non-clastogenic in mammaliancells in vitro(Kim, 2009 a) in either the absence or presence of an auxiliary metabolizing system (Morris, 2012) or non-genotoxic in the mouse (Kim, 2009 b). The test item is not a dermal irritant or a skin sensitizer (Bae, 2009 a; Bae, 2009 c; Pooles, 2010).
Description of key information
In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetic assessment has been conducted for the substance, DEHCH (Di 2-ethylhexyl cyclohexane-1,4-dicarboxylate). Summaries of studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII, point 8.8 of REACH. The assessment of the likely toxicokinetic behaviour of the substance was provided to the extent that can be derived from the relevant available information at the time of the assessment. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2012).
Key value for chemical safety assessment
Additional information
The substance is a clear colourless liquid and the molecular weight is 396.6 g/mol. The low vapour pressure value (7.45 x 10-4Pa at 50°C; Jeong, 2009) shows that the substance is non volatile therefore inhalation is not a significant route of exposure. The substance has a high log octanol/water partition coefficient value (Log10Pow8.84 Jeong, 2009) and low water solubility (47 μg/L; Jeong, 2009).The available repeated dose/reproductive screening study showed evidence of absorption and metabolism but did not show any evidence of excretion (Dunster, 2010).
The test item is non-mutagenic in bacteria (Kim, 2009 c), non-clastogenic in mammaliancells in vitro(Kim, 2009 a) in either the absence or presence of an auxiliary metabolizing system (Morris, 2012) or non-genotoxic in the mouse (Kim, 2009 b). The test item is not a dermal irritant or a skin sensitizer (Bae, 2009 a; Bae, 2009 c; Pooles, 2010).
Absorption
Results of the repeated dose/reproductive screening study in rats showed evidence to support the gastric absorption of the test item (Dunster, 2010). The relatively small molecular size of the substance should also allow absorption through passive diffusion. This is supported by the lipophilic nature of the substance (log10Pow8.84, Jeong, 2009). This would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. Limited absorption may also take place via the skin due to the relatively small molecular size. The low vapour pressure value (7.45 x 10-4Pa at 50°C; Jeong, 2009) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.
Distribution
Systemic distribution is evident from the repeated dose/reproductive screening study (Dunster, 2010) as a result of the organ changes observed. The lack of evidence to suggest the test item is a skin sensitizer suggests that it does not bind to carrier proteins in the circulatory system (Bae, 2009 c). Once absorbed, the substance may potentially accumulate in the adipose tissue due to the high log octanol/water partition coefficient value (Log10Pow8.84, Jeong, 2009).
Metabolism
The results of the repeated dose/reproductive screening study showed the evidence of an adaptive response in the liver and thyroids in rats (Dunster, 2010); which is normally associated with enhanced metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising systems (Kim, 2009 a; Kim, 2009 c).
Excretion
There is no evidence to indicate the route of excretion but poorly water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. As there is evidence of hepatic metabolism this does not, however, rule out urinary excretion. The main reason for xenobiotic metabolism is to render the product more water soluble thereby facilitating urinary excretion. Any test item that is not absorbed will be excreted in the faeces.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)