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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 239-914-1 | CAS number: 15816-71-4
- 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
Endpoint summary
Administrative data
Description of key information
In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) is hydrolytically very unstable so that in aqueous solution a rapid decomposition to the educts can be observed. The substance will rapidly dissociate to octanoic acid and dicyclohexylamine. Therefore Octanoic acid, compound with dicyclohexylamine (1:1) is not stable at “standard” testing conditions representative for human and environmental exposure. Hence, it is fully justified to apply the read-across methodology by use of the respective data from the breakdown/decomposition products to describe the toxicological behaviour of the substance.
Repeated dose toxicity data for octanoic acid:
Subchronic oral toxicity: NOAEL >= 7000 mg/kg bw
Chronic oral toxicity: NOAEL >= 8000 mg/kg bw
Repeated dose toxicity data for dicyclohexylamine:
subacute oral toxicity: NOAEL 20 mg/kg bw
The NOAEL of 20 mg/kg bw for dicyclohexylamine is used as key value for chemical safety assessment. Since the substance to be registered is Octanoic acid, compound with N-cyclohexylcyclohexanamine (1:1) which will dissociate to 1 mol octanoic acid and 1 mol dicyclohexylamine, the NOAEL of dicyclohexylamine is calculated for the entire substance considering the molar mass of 325.5 g/mol (55.7% dicyclohexylamine).
Therefore the NOAEL for Octanoic acid, compound with dicyclohexylamine (1:1) is 35.9 mg/kg bw.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 70 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Males, 13; females, 13: 0, 200 mg/kg bw
Males, 5, females, 5: 20, 70 mg/kg bw - Control animals:
- yes, concurrent vehicle
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- signs of intoxication such as salivation and convulsion at 70 and 200 mg/kg bw
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 8/13 rats given 200 mg/kg bw. both sexes
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- significantly decreased in rats of both sexes given 200 mg/kg bw/day
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- significantly decreased in rats of both sexes given 200 mg/kg bw/day
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Numbers of WBCs in females given 200 mg/kg bw/day were increased at the end of the administration period.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the blood chemical analysis at the end of the administration period, inorganic phosphorus and calcium concentrations were elevated in rats of both sexes given 200 mg/kg bw/day.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 200 mg/kg bw: weights of adrenal glands were elevated in animals of both sexes
70, 200 mg/kg bw: weights of ovaries were significantly decreased in female rats - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- haematology
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- Key result
- Critical effects observed:
- not specified
- Conclusions:
- The NOEL for the 28-day repeat dose oral toxicity test of dicyclohexylamine in rats is considered to be 20 mg/kg/day for both sexes.
- Executive summary:
Repeated dose toxicity of DCHA following oral application was tested in male and female CD rats for 28-days.
Animals received 0, 20, 70, and 200 mg/kg bw/day dissolved in corn oil by gavage. Control rats and the high dosed rats were kept for a 14-day recovery period.
Eight out of 13 rats died in both sexes given 200 mg/kg of dicyclohexylamine. Myocardial degeneration was observed in 1 dead male. In the other dead animals, no histological changes were found to explain the cause of death. Several signs, such as salivation, convulsion etc. which suggested certain neural effects were observed in the animals of both sexes given 70 mg/kg and more. These signs disappeared during the recovery period. Responses due to sympathetic stimulation caused by dicyclohexylamine was supposed to be one of the causes of death. Body weight and food consumption were significantly decreased in the animals of both sexes given 200 mg/kg. The lower body weight continued to the end of the recovery period, but food consumption had recovered by the end of the test. Numbers of WBCs in females given 200 mg/kg were increased at the end of the administration period. In the blood chemical analysis at the end of the administration period, inorganic phosphorus and calcium concentrations were elevated in the animals of both sexes given 200 mg/kg, suggesting that the dicyclohexylamine treatment had influenced phosphorus/calcium metabolism. The weights of the adrenal glands were elevated in the animals of both sexes given 200 mg/kg and the weights of ovaries were decreased in the animals given 70 mg/kg or more compared with those in the control group. The NOEL for the 28-day repeat dose oral toxicity test of dicyclohexylamine in rats is considered to be 20 mg/kg/day for both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 35.9 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Organ:
- adrenal glands
- blood
- ovary
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No specific target organ can be identified based on the available data in experimental animals. Therefore specific target organ toxicity to humans is not likely.
No classification for specific target organ toxicity is required.
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.