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EC number: 206-033-9 | CAS number: 294-62-2
- 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:
- 1993-12-23 to 1994-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Cyclododecane
- EC Number:
- 206-033-9
- EC Name:
- Cyclododecane
- Cas Number:
- 294-62-2
- Molecular formula:
- C12H24
- IUPAC Name:
- cyclododecane
- Details on test material:
- Test substance: Cyclododecane of Elf Atochem, C.A.L. No. 6589/92, purity >= 99.0 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Source: Charles River France (Saint-Aubin-les-Elbeuf)
- Age: approximately 6 weeks at beginning of treatment
- Weight at study initiation: females 178 g, males 199 g mean
- Number of animals:
control and high dose group: 12 per group and sex
50 and 150 mg/kg bw dose groups: 6 per group and sex
- Housing: two rats in wire.mesh cages
- Diet: ad libitum pelleted diet, A04 C
- Water: ad libitum, tab water
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C +/- 2 °C
- Humidity (%): 50 % */- 20%
- Air changes (per hr): 13 fold
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- ADMINISTRATION / EXPOSURE
- Vehicle: olive oil (Sigma)
- Total volume applied: 5 ml/kg bw/day
- Rate of preparation of substance: weekly - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Before start, the stability of the test substance suspended in olive oil was checked at 10 and 200 mg/ml,. From each preparation samples were taken
at 3 different levels (top, meddle, bottom) and gas chromatographically analyzed. On week 1 and 4 each preparation was checked for achieved
concentration of the test substance. The results of analyses revealed a good stability 9 days at 4 °C for investigated suspensions under the
conditions of preparation mentioned. Throughout the study a satisfactory concordance between obtained and nominal concentrations was found. - Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 150, or 1000 (day 1) / 500 (following days) mg/kg bw d
Basis:
- No. of animals per sex per dose:
- control and high dose group: 12 per group and sex
50 and 150 mg/kg bw dose groups: 6 per group and sex - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 2 weeks (designated animals of control and high dose groups)
On day 2, before treatment, 1/12 females given 1000 mg/kg was found dead and 2/12 females of the same group were prematurely killed due to
poor clinical condition. Therefore, the high dose level for this group was reduced to 500 mg/kg/day from day 2 until the end of the treatment period. - Positive control:
- no positive control
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: at least twice daily (same time of day)
- Mortality: at least twice daily including weekends
- Body weight: before treatment and once a week including recovery period
- Food consumption: once a week including recovery period
- Haematology: day 27 (24 hours after preceding treatment and without food)
- Biochemistry: day 27; for some parameters and recovery test animals also at the end of the recovery period
- Urinalysis: day 27; for recovery test animals also at the end of the recovery period - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopic: weights of adrenals, brain, heart, kidneys, liver, mesenteric and mandibular lymph nodes, ovaries, spleen, testes, thymus, thyroids
with parathyroids examination of adrenals, aorta, brain including medulla / pons, cerebellar and cerebral cortex, caecum, colon, duodenum,
eyes with Harderian glands, femoral bone with articulation, heart, ileum, jejunum, kidneys, liver, lungs with bronchi, lymph nodes (mandibular and mesenteric), mammary glands, oesophagus, ovaries, pancreas, pituitary gland, prostate, rectum, sciatic nerve, seminal vesicle, skeletal muscle,
skin, spinal cord (cervical, thoracic and lumbar), spleen, sternum (with bone marrow), stomach, salivary glands (sublingual and submaxillary),
testes and epididymides, thymus, thyroids with parathyroids, trachea, tongue, urinary bladder, uterus (horns and cervix), vagina
- Microscopic:
high dose group and controls plus prematurely died animals: all macroscopic lesions and adrenals, duodenum, heart, kidneys, liver, lungs with
bronchi, ovaries, spleen, stomach, testes and epididymides, thymus, thyroids with parathyroids
other groups: all macroscopic lesions and lungs, liver, kidneys - Other examinations:
- no other examinations
- Statistics:
- STATISTICAL METHODS: sequence as follows:
- normality of distribution (Kolmogorov-Smirnov's test)
- homogeneity of variances: Fisher's test (2 groups) or
Bartlett's test (> 2 groups)
- no significant heterogeneity: Dunnett's test
- heterogeneous variances: Mann Whitney's test (2 groups) or Dunn's test (> 2 groups)
- no normal distribution: repeat analysis after logarithmic transformation (except for organ weights)
- still no normal distribution: Dunn's test (original values)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: On day 2, 1/12 females was found dead and 2/12 females were prematurely killed due to poor clinical conditions. No
other mortalities occurred during the treatment or recovery periods.
- Clinical signs: Signs of poor clinical condition and locomotory difficulties were noted in females given 1000 mg/kg/day on day 1. After the
decrease of the high dose level to 500 mg/kg/day, these clinical signs disappeared. Ptyalism was observed at all dose levels during the treatment
period.
- Body weight gain: No relevant effects on body weight were noted in treated animals during the treatment and recovery periods.
- Food consumption: A slight increase in food consumption was noted in the females of the high dose group during the last week of
treatment. Evidence of reversibility was found.
- Clinical chemistry: Slight to moderate decrease in glucose level was noted in males and females of the high dose group. Evidence of reversibility
was found.
- Haematology: No relevant findings were noted in treated animals.
- Urinalysis: No findings of toxicological significance were found at the end of the treatment or recovery period.
- Organ weights: An increase in kidney weight was noted in males at all dose levels, and an increase in liver weight was noted in females of the
high dose group. Evidence of reversibility was found.
- Gross pathology: Irrecular colour of the kidneys was noted in males of the high and medium dose groups. Evidence of reversibility was found.
- Histopathology: In line with the increase in liver weight, hepatocellular hypertrophy was noted in females of the high dose group. In line with the
increase in weights and the irregular colour, excessive acidophilic globules were found in the cortical tubular epithelium of the kidneys of the
treated males at all dose levels. Evidence of reversibility was found for these microscopic findings.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- For all findings, evidence of reversibility was found after
two weeks without treatment. Therefore, in the experimental
conditions of the study, the
No Observable Adverse Effect Level is reported as 150 mg/kg bw/day. - Executive summary:
In this 28-day repeated dose oral toxicity study three groups of male and female rats were dosed with 50, 150, and 500 mg (except first day 1000mg/kg) Cyclododecane/kg bw daily for 4 weeks by oral gavage. A concurrrent control group received olive oil only. The test material was diluted in olive oil at a temperature of about 61 °C and prepared weekly. First 6 animals of the control and the high dose group remained untreated after the 4 weeks applicationn period for a 2 week recovery period. The daily administration of cyclododecane induced mortalities and poor clinical conditions in females after one treatment at 1000 mg/kg/day, ptyalism at all dose levels and a slight increase in food consumption in females given 1000/500 mg/kg/day. A decrease in glucose level was noted at 1000/500 mg/kg/day and granular casts were found in the urine of males at all dose levels. In addition, an increase in liver weight, correlated to hepatocellular hypertrophy was noted in femals given 1000/500 mg/kg/day. An increase in kidney weights correlated to irregular colour and presence of acidophilic globules (due to the presence of alpha 2 µ globulin) in the cortical tubular epithelium was found in males at all dose levels, and were considered to be of no toxicological significance, in regard to the specificity of this urinary protein in the male rat. For all these findings, evidence of reversibility was found after two weeks without treatment. Therefore, under this experimental conditions, the No Observe Adverse Effect level is 150 mg/kg/day.
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