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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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Dicyclohexylamine:
In an OECD reproduction/developmental toxicity screening test (OECD TG 421) in rats dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day) including slightly reduced gestation index, increase in stillborn pups and decrease in live born pups. The NOAEL (reproductive toxicity) is 80 mg/kg bw/day for males and 40 mg/kg bw/day for females. The NOAEL (offspring) is 40 mg/kg bw/day based on significant reduction in pup weights on day 0 and slight reduction in pup weights on day 4 in offspring of the parents dosed with 80 mg/kg bw/day. These adverse effects on the development of the F1-generation occur only in the presence of severe maternal toxicity.
Octanoic acid:
A casein diet, containing 18.5% MCT (medium chain triglycerides) and 2.5% safflower oil was compared with similar diets containing conventional dietary fats. The MCT contained about 51% octanoic acid and 35% Decanoic arid resulting in an Octanoic acid dietary dose of about 4700 mg/kg bw day and a Decanoic acid dietary dose of about 3200 mg/kg bw day.
The 47-week study showed that the MCT diet supported normal growth and development. The MCT diet supported normal reproduction, as indicated by litter size and number.
Accordingly for Decanoic acid and Octanoic acid as medium chain triglycerides an overall NOAEL of ≥ 8000 mg/kg bw day is apparent in this study.
Since for octanoic acid, naturally present in many types of food, no concern for reproductive toxicity is given, data from reproductive toxicity studies with dicyclohexylamine are used.
For effects on fertility the NOAEL of 40 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 dicyclohexylamine (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 71.81 mg/kg bw.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- 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:
- Males: 49 days
Females: from 14 days before mating to day 3 of lactation - Frequency of treatment:
- once daily
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Dose / conc.:
- 80 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Parental animals: Observations and examinations:
- clinical signs of toxicity, body weight, mortality, pathology of male organs, number of pairs mated, number of pairs copulated, number of pregnant females, days until copulation, copulation index (no. of pairs with successful copulation / no. of pairs mated) X 100 fertility index (no. of pregnant rats / no. of pairs with successful copulation) X 100duration of gestation, ---gestation index(no. of females with live pups / no. of pregnant females) X 100, ---implantation index (no. of implantations / no. of corpora lutea) X 100
- Oestrous cyclicity (parental animals):
- estrus cycle length
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- live birth index (no. of live pups on day 0 / no. of pups born) X 100, ---delivery index (no of pups born / no. of implantations) X 100, ---sex ratio (no of males /no of females), ---viability index (no of live pups on day 4 / no. of live pups on day 0) X 100, body weight of pups on day 0 and day 4
- Postmortem examinations (parental animals):
ORGANS EXAMINED AT NECROPSY (reported organs): --Organ weight (absolute and relative): - male, right and left testes, right and left epididymides- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- unspecific signs of intoxication
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- In the 80 mg/kg bw/day-group, 1 dam died on day 21 and another dam on day 22 of gestation.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Suppression of body weight gain in both sexes (male: treated rat versus control: 507 g versus 543 g) and low food consumption were observed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- 80 mg/kg:
Number of stillborn pups was significantly increased (55 versus 11 in controls) and the number of live born pups significantly decreased (72 versus 169 in controls) as well as live born index (58 % versus 94 % in controls), viability index reduced in pups (20.8 % versus 99 % in controls), pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically significantly reduced (m/f: 9.0 g/8.6 g versus 11.8 g/11.1 g), poor maternal behavior and nursing observed in 7 dams. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 80 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no effects
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- Offsprings of the 80 mg/kg bw/day-dosed animals:number of stillborn pups significantly increased (55 versus 11 in controls),number of live born pups significantly decreased (72 versus 169 in controls) as well as live born index (58 % versus 94 % in controls), viability index reduced in pups of the 80 mg/kg bw/day group (20.8 % versus 99 % in controls) and pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Pup weights on day 0 significantly (m/f: 6.1 g/5.5 g versus 7.3 g/7.0 g) and on day 4 slightly but not statistically
significantly reduced (m/f: 9.0 g/8.6 g versus 11.8 g/11.1 g) - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not specified
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Critical effects observed:
- not specified
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- In an OECD reproduction/developmental toxicity screening test (OECD TG 421) in rats dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day) including slightly reduced gestation index, increase in stillborn pups and decrease in live born pups. The NOAEL (reproductive toxicity) is 80 mg/kg bw/day for males and 40 mg/kg bw/day for females. The NOAEL (offspring) is 40 mg/kg bw/day based on significant reduction in pup weights on day 0 and slight reduction in pup weights on day 4 in offspring of the parents dosed with 80 mg/kg bw/day. These adverse effects on the development of the F1-generation occur only in the presence of severe maternal toxicity.
- Executive summary:
In an OECD reproduction/developmental toxicity screening test (OECD TG 421) in rats dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day) including slightly reduced gestation index, increase in stillborn pups and decrease in live born pups. The NOAEL (reproductive toxicity) is 80 mg/kg bw/day for males and 40 mg/kg bw/day for females. The NOAEL (offspring) is 40 mg/kg bw/day based on significant reduction in pup weights on day 0 and slight reduction in pup weights on day 4 in offspring of the parents dosed with 80 mg/kg bw/day. These adverse effects on the development of the F1-generation occur only in the presence of severe maternal toxicity.
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 47 weeks reproduction/developmental study
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Mc Collum Wisconsin
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 47 weeks
- Frequency of treatment:
- ad libitum
- Dose / conc.:
- 4 700 mg/kg bw/day (nominal)
- Remarks:
- 40% of daily
calories in food
supplied by MCT - No. of animals per sex per dose:
- not specified
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 8 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Key result
- Critical effects observed:
- no
- Immunological findings:
- not specified
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 8 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- >= 8 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- A casein diet, containing 18.5% MCT (medium chain triglycerides) and 2.5% safflower oil was compared with similar diets containing conventional dietary fats. The MCT contained about 51% octanoic acid and 35% Decanoic arid resulting in an Octanoic acid dietary dose of about 4700 mg/kg bw day and a Decanoic acid dietary dose of about 3200 mg/kg bw day.
The 47-week study showed that the MCT diet supported normal growth and development. The MCT diet supported normal reproduction, as indicated by litter size and number.
Accordingly for Decanoic acid and Octanoic acid as medium chain triglycerides an overall
NOAEL of ≥ 8000 mg/kg bw day is apparent in this study. - Executive summary:
A casein diet, containing 18.5% MCT (medium chain triglycerides) and 2.5% safflower oil was compared with similar diets containing conventional dietary fats. The MCT contained about 51% octanoic acid and 35% Decanoic arid resulting in an Octanoic acid dietary dose of about 4700 mg/kg bw day and a Decanoic acid dietary dose of about 3200 mg/kg bw day.
The 47-week study showed that the MCT diet supported normal growth and development. The MCT diet supported normal reproduction, as indicated by litter size and number.
Accordingly for Decanoic acid and Octanoic acid as medium chain triglycerides an overall NOAEL of ≥ 8000 mg/kg bw day is apparent in this study.
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to REACH Annex XI, section 1, the standard testing regime may be adapted if testing does not appear scientifically necessary.
In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) will rapidly dissociate to octanoic acid and dicyclohexylamine.
Octanoic acid is a linear saturated fatty acid and is ubiquitous in nature.
According to Umweltbundesamt GmbH on behalf of Federal Ministry of Agriculture, Forestry, Environment and Water Management octanoic acid is not genotoxic (citation):
“Data obtained in a 47-week study showed that the MCT diet supported normal growth and development. The MCT diet supported normal reproduction, as indicated by litter size and number. However weight gain of F1 rats was highest with the oleo oil diet, lower with the MCT diet but lowest with the low-fat diet. Accordingly for Decanoic acid and Octanoic acid as medium chain triglycerides an overall NOAEL of ≥ 8000 mg/kg bw day is apparent in this study. Taking furthermore into consideration the arguments listed in chapter 4.7 (bullet points) there is no concern for reproductive toxicity.”
“Data for potential effects on fertility are available with medium chain fatty acid triglycerids. Data for potential effects on the development are available for octanoic acid and for nonanoic acid. None of these data indicate a concern for reproductive toxicity. However this is also not to be expected given the knowledge on metabolism in humans and daily exposure to fat as nutrient.”
Referenceopen allclose all
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 71.81 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- no study required
Justification for classification or non-classification
DCHA:
Dicyclohexylamine revealed effects on reproduction only in females at the highest oral dose tested (80 mg/kg bw/day). Since at these dose level mortality was observed, the effects on reproductive performance is considered only as secondary to massive maternal toxicity.
Octanoic acid:
Since for octanoic acid, naturally present in many types of food, no concern for reproductive toxicity is given.
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, data from the respective dissociation products dicyclohexylamine and octanoic acid are used for classification and labelling purposes.
Since the observed adverse effects of dicyclohexylamine on the development of the F1-generation occur only in the presence of severe maternal toxicity and octanoic acid is devoid of any reproductive toxicity, no classification of Octanoic acid, compound with N-cyclohexylcyclohexanamine (1:1) for reproductive toxicity is required.
Additional information
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.
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