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EC number: 417-060-2 | CAS number: 151006-61-0 1-DODECENE DIMER, HYDROGENATED; ALKANE 2
- 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:
- 1993-09-29 to 1993-10-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restriction because although the study closely adhered to OECD 407 guidelines, haematology, clinical biochemistry, and neurobehavioral assessments were not conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Haematology, clinical chemistry, and neurobehavioural tests were not performed
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- EC Number:
- 500-183-1
- EC Name:
- Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated
- Cas Number:
- 68037-01-4
- IUPAC Name:
- Dec-1-ene, homopolymer, hydrogenated
- Details on test material:
- - Substance type: 1-Decene, homopolymer, hydrogenated
- Physical state: Liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Not reported
- Lot/batch No.: 2309
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Cool temperature (not to exceed 15 decrees Celsius) in the dark
- Other: Identity, strength, composition, and stability were stated to be the responsibility of the sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Limited, England
- Age at study initiation: 35 to 42 days old
- Weight at study initiation: Not reported, but stated to weight between 59 and 76 grams the day after arrival
- Housing: Five per stainless steel cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55%
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From:1993-09-29 To: 1993-10-28
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): Weekly
- Mixing appropriate amounts with ground diet
- Storage temperature of food: 21 degrees Celsius
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity was tested on the lowest and highest concentration by taking 6 samples from different positions in the mixer. The dose formulation was determined to be homogeneous. Stability was determined on the highest and lowest concentrations after 1 and 2 weeks. The dose formulation was determined to be stable for at least 2 weeks. Dietary concentrations were analysed during week 1 and 4. Dose formulations were within 10% of nominal dose.
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 8000; 20,000; or 50,000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- Five per sex per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: Based on studies performed using similar materials
- Rationale for animal assignment (if not random): Random - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations included overt signs of toxicity and faecal examination.
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Study initiation, twice weekly during treatment, and at study termination
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: 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: Yes
- Time schedule for examinations:No quantitative measurement was made, but water bottles were observed daily to check for any changes that might indicate a treatment-related change in fluid balance
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, detailed necropsy was performed.
HISTOPATHOLOGY: Yes, although numerous tissues and organs were preserved, only the liver and mesenteric lymph nodes were examined histologically. - Other examinations:
- Organs provided in table 1 were weighed.
- Statistics:
- A Bartlett's test was used to test for homogeneity of the data. Depending on the results a Behrens-Fisher or Dunnett's test were performed. Fischer's exact test was used on microscopic and macroscopic findings.
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 specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- 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
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects.
BODY WEIGHT AND WEIGHT GAIN: High-dose females had a marginal increase in body weight gain. However, this was related to increased food consumption so was considered due to individual variability and not treatment-related.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): High-dose females had a slight increase in food consumption. Compound intake in males was 1030, 2538, and 6248 mg/kg/day for the 8000 ppm; 20,000 ppm; and 50,000 ppm dose groups, respectively. Compound intake in females was 995, 2481, and 6771 mg/kg/day, respectively.
FOOD EFFICIENCY: There were no treatment-related effects.
ORGAN WEIGHTS: There was a slight, but dose-related, decrease in absolute and relative mandibular weight in males and females that reached statistical significance in high-dose females only.
GROSS PATHOLOGY: There were no treatment-related effects.
HISTOPATHOLOGY: There were no treatment-related effects.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 6 245 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Overall effects
- Dose descriptor:
- NOAEL
- Effect level:
- 6 771 mg/kg bw/day (actual dose received)
- Sex:
- 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 was an apparent dose-related decrease in mandibular lymph node weight, the results only reached significance in high-dose females; therefore, this is not considered biologically significant and not likely adverse since there were no other findings.
Applicant's summary and conclusion
- Conclusions:
- The systemic NOAEL for dec-1-ene, homopolymer, hydrogenated in the diet is 50,000 ppm, which is equivalent to a daily intake of 6245 mg/kg/day in males and 6771 mg/kg/day in females.
- Executive summary:
In a repeated dose oral toxicity study, dec-1 -ene, homopolymer,hydorgenated was administered to F-344 rats (5 sex/dose) in the diet for four weeks at nominal concentrations of 0, 8000; 20,000; or 50,000 ppm (equivalent overall mean daily intakes were 1039, 2538, or 6245 mg/kg/day for males and 995, 2481, or 6771 mg/kg/day for females).
There was no overt toxicity or mortality observed in male or female rats during the study. Overall body weight gain and food consumption of females in the 50,000 ppm dose group was higher than the corresponding controls. A dose-dependent decrease in mandibular lymph node weights (absolute and relative to body weight) was observed in males and females; however, these results were statistically significant only for 50,000 pm females. Gross necroscopy, histopathology, and microscopic findings did not reveal any significant treatment-related findings in either male or female rats. Dietary administration of dec-1 -ene, homopolyer, hydrogenated to male and female F-344 rats at levels up to 50,000 ppm for 4 weeks did not produce toxicologically significant effects. Therefore, the subacute oral NOAEL for dec-1 -ene, homoopolymer, hydrogenated is 6245 mg/kg/day in males and 6771 mg/kg/day in females.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because although the study closely adhered to OECD 407 guidelines, haematology, clinical biochemistry, and neurobehavioral assessments were not conducted. This study will influence the DNEL.
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