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Diss Factsheets
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EC number: 947-344-6 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octanoic acid, 4-methyl-2-pentylbutyl ester
- Cas Number:
- 868839-23-0
- Molecular formula:
- C18H36O2
- IUPAC Name:
- Octanoic acid, 4-methyl-2-pentylbutyl ester
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- soya oil
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Dose regimen: 7 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 per sex for each dosage group
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- Clinical Observations
One female animal dosed with 100 mg/kg bw/day of the test substance showed moderate to severe increased
drinking water consumption and diuresis from test day 40 onwards. The same animal showed pilo-erection
from test day 72-78. As this was an isolated observation this was considered not to be test related. No other
effects on behaviour or external appearance were observed in the treated animals.
Body weight changes and food consumption in the treated animals corresponded to that seen in the control
animals.
The observation and functional screening did not reveal any test item related changes at any dose level.
No test item related changes in the oestrus cycle were found at any dose level.
No test item related effects on sperm count, viability or mobility were observed.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item related changes were noted in the haematological parameters at any dose level.
No test item related changes were noted in the biochemical parameters at any dose level.
Male and female animals in the mid and high dose treatment groups showed a statistically significant decrease in the urinary pH value of between 5 and 11% which was considered to be related to treatment with the test item. The urinary specific gravity values for male rats in the mid dose group also showed a slight but statistically significant decrease, however, as it was not dose related it was considered to be unrelated to the test item. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No test item mortality occurred during the study. However, four female animals died during laboratory examinations on the last day after blood withdrawal due to ether narcosis.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Animals in the high dose treatment group showed a statistically significant increase in the absolute and relative liver weights. No other test related macroscopic or microscopic changes in the organs were noted.
The changes in the liver weights were considered to be a non-specific adaptive change to the high workload of the liver at the maximum dose. - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female animal dosed with 100 mg/kg bw/day of the test substance showed moderate to severe increased drinking water consumption and diuresis from test day 40 onwards. The same animal showed pilo-erection from test day 72-78. As this was an isolated observation this was considered not to be test related. No other effects on behaviour or external appearance were observed in the treated animals.
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Male and female animals in the mid and high dose treatment groups showed a statistically significant decrease in the urinary pH value of between 5 and 11% which was considered to be related to treatment with the test item.
The urinary specific gravity values for male rats in the mid dose group also showed a slight but statistically significant decrease, however, as it was not dose related it was considered to be unrelated to the test item.
The test related decrease in urinary pH is considered to be possibly due to an acidic metabolite of the test item eliminated at large doses via the urine. Therefore, in the absence of any observed effects on the kidney this is considered to be a non-adverse effect. - Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Animals in the high dose treatment group showed a statistically significant increase in the absolute and relative liver weights. No other test related macroscopic or microscopic changes in the organs were noted.
The changes in the liver weights were considered to be a non-specific adaptive change to the high workload of the liver at the maximum dose. - Gross pathological findings:
- effects observed, non-treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Propylheptyl Caprylate : NOAEL >= 1000 mg/kg bw
The No Observed Adverse Effect Level (NOAEL) was established as ≥ 1000 mg/kg bw/day in this study based on the absence of adverse treatment related effects.
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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