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EC number: 217-031-2 | CAS number: 1724-39-6
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-12-16 to 1997-01-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Cyclododecanol
- EC Number:
- 217-031-2
- EC Name:
- Cyclododecanol
- Cas Number:
- 1724-39-6
- Molecular formula:
- C12H24O
- IUPAC Name:
- cyclododecanol
- Details on test material:
- Cyclododecanol of Hüls AG, Sample from drum 1-358, ID 0637/81783, produced Jan/Feb 1996. Purity 99.4 % (GC-FID area).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Age: young adults
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation:
test group, male: 27.5 +/- 5.5 g
test group, female: 28.4 +/- 5.7 g
- No. of animals per dose: 5 males, 5 females per test duration
Environmental conditions:
- feed: R 10 diet for rats (Ssniff; Soest, Germany)
- water: tap water ad libitum
- room temperature: 22°C (+/- 3°C)
- humidity: 30% - 70%)
- air change: 15 times/hour
- light-dark rhythm: 12 hours light/dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- ADMINISTRATION:
- Vehicle: corn oil
- Control groups and treatment:
negative: vehicle
positive: 100 mg cyclophosphamide (CPA)/kg bw in 0.9 % aqueous NaCl
additional treated satellite group to replace mortalities
- Total volume applied: 10 ml/kg bw
- Duration of test: 24 hours; 48 hours
- Sampling times and number of samples: 24 hours; 48 hours - Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- 1 time
- Post exposure period:
- 24 and 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 100 mg cyclophosphamide (CPA)/kg bw in physiological NaCl solution per oral gavage
Examinations
- Tissues and cell types examined:
- polychromatic erythrocytes of the bone marrow from femur
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
- Criteria for selection of M.T.D.: highest dosage <= 2000 mg/kg bw without mortalities within 48 hours
EXAMINATIONS:
- Clinical observations: yes
- Organs examined at necropsy: femur bone marrow; others not specified in report >= 2000 PCE (polychromatic erythrocytes) per animal were
analysed for micronuclei
DETAILS OF SLIDE PREPARATION:
Animals were sacrified at appropriate sampling times. Femurs were removed and bone marrow cells obtained by flushing with foetal calf serum.
The cells were centrifuged and a concentrated suspension prepared to make smears on slides. Slides were air-dried and then stained with
May-Gruenwald and Giemsa. Three slides were made from each animal, >= 2000 PCE (polychromatic erythrocytes) per animal were analysed for
micronuclei - Evaluation criteria:
- Criteria for evaluating results: Statistically significant and biologically relevant increase in frequency of micronucleated polychromatic erythrocytes
of at least one test group as compared to the negative control group of the same sampling time - Statistics:
- - Degree of heterogeneity within each group was first calculated and in case all the groups are homogenous, comparisons can be made
between the control and test groups
- a modified chi-squared calculation was employed to compare treated and control groups
- Chi-squared values are taken to show the significance of any difference between each treated group and the controls
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- No mortality was observed at oral dose of 2000 mg/kg bw. All animals sowed clinical symptoms (e.g.hunched posture, piloerection, diarrhea).
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- MORTALITY:
- Phase 1 of dose finding = 2000 mg/kg bw: No mortalities within 48 hours among 5 males + 5 females. No further phases were required.
- Main test: No mortalities
CLINICAL SIGNS: Predominant signs in the dose finding study were hunched posture (only males), piloerection, and diarrhea (1/5 males,
1/5 females). Observations in the main study were similar but additionally included a few cases of slight sedation, staggering, and tremor.
The clinical symptoms indicate that the test substance or its metabolites had reached the blood and hence the target organ, i.e. the bone marrow.
NECROPSY FINDINGS: No necropsy reported.
EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO:
The average PCE/NCE ratio of the positive control groups was significantly lower than that of the corresponding vehicle controls
(0.23 +- 0.08 vs 0.63 +- 0.34 for males, 0.38 +- 0.12 vs 1.57 +- 0.80 for females).
The PCE/NCE ratio was not significantly influenced by treatment with the test substance.
GENOTOXIC EFFECTS:
The micronucleus frequencies of the negative controls were within the range of historical control data of the performing laboratory.
For the positive control a significant increase in the frequency of micronucleated polychromatic erythrocytes was observed
(4.11 +- 1.20 vs 0.11 +- 0.09 for males; 2.78 +- 1.32 vs 0.13 +- 0.10 for females).
No statistically significant or biologically relevant increase in the frequency of micronucleated polychromatic erythrocytes over the control was
found with the males and females treated with the test substance.
Any other information on results incl. tables
--------------------------------------------------------
Treatment Sex Time % Micron. in PCE PCE/NCE
--------------------------------------------------------
2000 T.S. m 24 h 0.14 +- 0.10 0.78 +- 0.33
2000 T.S. m 48 h 0.12 +- 0.08 0.98 +- 0.22
2000 T.S. f 24 h 0.09 +- 0.07 1.32 +- 0.69
2000 T.S. f 48 h 0.08 +- 0.06 2.27 +- 1.51
Vehicle m 24 h 0.11 +- 0.09 0.63 +- 0.34
Vehicle m 48 h 0.18 +- 0.12 0.89 +- 0.34
Vehicle f 24 h 0.13 +- 0.10 1.57 +- 0.80
Vehicle f 48 h 0.11 +- 0.08 1.25 +- 0.28
100 CPA m 24 h 4.11 +- 1.20 *** 0.23 +- 0.08 *
100 CPA f 24 h 2.78 +- 1.32 ** 0.38 +- 0.12 **
--------------------------------------------------------
T.S. = test substance (cyclododecanol; mg/kg bw)
CPA = cyclophosphamide (mg/kg bw)
* p < 0.05; ** p < 0.01; *** p < 0.001
--------------------------------------------------------
The clinical symptoms indicate that the test substance or its metabolites had reached the blood and hence the target organ, i.e. the bone marrow.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The results of this study indicate that under the test conditions, Cyclododecanol did not induce micronucleated polychromatic erythrocytes in male
and female mice. - Executive summary:
In this in vivo mouse micronucleus assay 2000 mg/kg bw Cyclododecanol was administered oral to 5 male and 5 female NMRI mice per group. This doses were selected as the maximum tolerated dose (MTD) based upon a preliminary toxicity study. Bone marrow polychromatic erythrocytes, collected 24, and 48 hours after single treatment, were examined microscopically for micronucleated polychromatic erythrocytes (PCE). No significant increase in the frequency of PCE over the control was found with any group treated with the test substance. For the positive control (cyclophosphamid, CPA) a significant increase in the frequency of PCE was observed.
Therefore, the conclusion is drawn, that Cyclododecanol is not a mutagenic substance under the in vivo conditions in this micronucleus assay using male and female NMRI mice.
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