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EC number: 604-766-2 | CAS number: 151006-58-5
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-03-08 to 1989-06-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it closely followed OECD 407 guidelines and was GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 11-methylhenicosane; 8-ethyl-9-methylheptadecane; 9-methylhenicosane
- EC Number:
- 604-766-2
- Cas Number:
- 151006-58-5
- IUPAC Name:
- 11-methylhenicosane; 8-ethyl-9-methylheptadecane; 9-methylhenicosane
- Details on test material:
- - Substance type: C10/C12 poly alpha olefin
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: KWA 88-01217
- Stability under test conditions: Considered stable
- Storage condition of test material: Ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories (Portage, Michigan)
- Age at study initiation: 41 days old
- Weight at study initiation: Males: 161 to 204 grams; Females: 133 to 169 grams
- Housing: Individually in hanging stainless steel wire-bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 46 to 76%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From:1989-04-06 To:1989-06-14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Test compound was mixed weekly by weight per volume in peanut oil.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not reported
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): Adjusted weekly to body weight
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were found to be stable and homogeneous. Doses were generally within 10% of the nominal concentration.
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 200, 500, or 1000 mg/kg/day
Basis:
other: nominal in oil
- No. of animals per sex per dose:
- 6 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based on a pilot 2 week repeat dose toxicity study
- Rationale for selecting satellite groups: Not reported
- Post-exposure recovery period in satellite groups: 2 weeks
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- Cage side observations included viability checks.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily for changes in skin, fur, eyes, mucus membrane, respiratory system, autonomic and central nervous system, somatomotor activity, and behavioural patterns; Pupil response was checked on day 0 and then weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, twice weekly, and once weekly during recovery period
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Terminal sacrifice
- Anaesthetic used for blood collection: Yes (sodium pentabarbitol)
- Animals fasted: Yes
- How many animals: All animals
- Parameters checked in Table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Terminal sacrifice
- Animals fasted: Yes
- How many animals: All animals
- Parameters checked in Table 2 were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: Overnight prior to study termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes
- Parameters checked in Table 3 were examined.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, included external surfaces; all orifices; the cranial, thoracic, and abdominal cavities
HISTOPATHOLOGY: Yes (see table 4) - Other examinations:
- The following organs were weighed: Brain, kidneys, adrenals, and testes/ovaries.
- Statistics:
- A one-way analysis of variance and Dunnett's test on continuous variables in the main study. An analysis of variance followed by a Student's t-test was used on the data from the recovery groups. Differential white blood cell counts were analysed using a non-parametric Kruskal Wallis ANOVA followed by Mann-Whitney U test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- 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:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Although there were some statistically significant effects, none of the effects were considered toxicologically significant or treatment-related.
Applicant's summary and conclusion
- Conclusions:
- The test compound did not cause any toxicologically significant or treatment-related results. Therefore, the NOAEL is 1000 mg/kg/day.
- Executive summary:
In a repeated dose oral toxicity study, 1-Dodecene, dimer with 1-decene, hydrogenated was administered to 6 Sprague-Dawley rats/sex/dose at dose levels 0, 200, 500, or 1000 mg/kg bw/day for 29 days. A recovery group (6 rats), dosed with 0 or 1000 mg/kg/day of the test substance, was observed for two weeks post-dosing. Each animal was observed daily for toxicological changes one hour post-dosing. Blood analysis, urinalysis, and necropsies were conducted post-sacrifice. The test conditions complied with the guideline requirements for this study type and the statistical methods used were appropriate.
No mortality, compound-related systemic toxicity or pathological changes were observed in the study or recovery groups at the limit dose of 1000 mg/kg 1-Dodecene, dimer with 1-decene, hydrogenated. Statistically significant changes occurred in food consumption, haematology, serum chemistry, and organ weights; however, none of the changes were considered to be of toxicological significance. No LOAEL could be determined due to lack of any affects. The NOAEL is 1000 mg/kg/day.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it closely followed OECD 407 guidelines and was GLP compliant.
This study will influence the DNEL.
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