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EC number: 915-334-0 | 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
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:
- weight of evidence
- Study period:
- 13 Aug - 12 Oct 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. There was no negative control for the 48-h sampling time, the purity of the test substance was not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted Sep 2014
- Deviations:
- yes
- Remarks:
- no negative control group for the 48-h sampling time; purity of the test substance not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Staatsministerium für Arbeit, Familie und Sozialordnung, München
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- octadecyl heptanoate; octadecyl octanoate
- EC Number:
- 915-334-0
- Molecular formula:
- C25H50O2 C26H52O2
- IUPAC Name:
- octadecyl heptanoate; octadecyl octanoate
- Details on test material:
- - Name of test material (as cited in study report): stearyl heptanoate (and) stearyl caprylate
- Physical state: waxy, colourless solid
- Analytical purity: no data
- Lot/batch No.: A:257032
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl:NMRI BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: adult (approximately 3 months)
- Weight at study initiation: 21 g ± 15%
- Assigned to test groups randomly: yes
- Housing: animals were housed in groups of 5 in Macrolon cages
- Diet: rat/mouse/hamster feed, pellets (Eggersmann Futtermittelwerk, Rinteln, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 - 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw - Duration of treatment / exposure:
- not applicable
- Frequency of treatment:
- single treatment
- Post exposure period:
- 24 h after treatment (500 and 1500 mg/kg bw group)
24 and 48 h after treatment (5000 mg/kg bw group)
24 h after treatment (control groups)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1500 and 5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, concurrent vehicle. 2 negative control groups were used for the 24-hour sampling time and none for the 48-hour sampling time; no justification was given.
- Positive control(s):
- cyclophosphamide
- Route of administration: oral, gavage
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A range-finding study was performed to identify the maximum tolerated dose.
DETAILS OF SLIDE PREPARATION:
Slides were fixed with methanol for 5 minutes and stained with a May-Grünwald and Giemsa solution. Two slides per animal were prepared.
METHOD OF ANALYSIS:
A total of 1000 polychromatic erythrocytes were examined per slide and the number of micronucleated cells were recorded. The ratio of polychromatic erythrocytes to normochromatic (mature) erythrocytes was calculated for a sample of 1000 cells. All slides were randomised before analysis. - Evaluation criteria:
- The frequency of micronuclei in the polychromatic erythrocytes and the ratio of polychromatic erythrocytes to normochromatic (mature) erythrocytes were compared with the negative control groups, the positive control group and the historical data.
- Statistics:
- The data were analysed using a likelihood ratio test. Individual animal results were used as data points in the analysis. The set of micronuclei in polychromatic erythrocytes among the control groups were compared with the set of each treatment time.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5000 mg/kg bw
- Clinical signs of toxicity in test animals: there were no signs of toxicity during the 48-h observation period
- Rationale for exposure: the dose was selected based on the maximum dose level recommended by regulatory bodies
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): the number of polychromatic erythrocytes with or without micronuclei and the number of normochromatic erythrocytes in the treatment groups at different sampling times did not differ significantly from the number for the vehicle control groups and historical vehicle control data (see Table 1 - 4 under 'Any other information on results incl. tables').
- Ratio of PCE/NCE (for Micronucleus assay): the ratio for the treatment groups at different sampling times did not differ significantly from the ratio for the vehicle control groups and historical vehicle control data (see Table 1 - 4 under 'Any other information on results incl. tables').
- Other: no clinical signs were observed during the 48-h observation period.
Any other information on results incl. tables
Table 1: Results of the in vivo micronucleus assay in male animals
|
Mean PCEs / 1000 NCEs at sampling time |
Total micronuclei per 1000 PCEs at sampling time |
||||
Group |
Number of animals |
Dose [mg/kg bw] |
24 h |
48 h |
24 h |
48 h |
Vehicle control I (corn oil) |
5 |
0 |
498.5 ± 54.4 |
n.d. |
2.20 ± 1.10 |
n.d. |
Vehicle control II (corn oil) |
5 |
0 |
507.4 ± 78.6 |
n.d. |
2.20 ± 1.10 |
n.d. |
Positive control (cyclophosphamide) |
5 |
40 |
555.0 ± 116.2 |
n.d. |
41.8 ± 7.92 |
n.d. |
Test substance |
5 |
500 |
546.4 ± 125.5 |
n.d. |
2.0 ± 1.22 |
n.d. |
Test substance |
5 |
1500 |
545.0 ± 81.9 |
n.d. |
1.20 ± 0.84 |
n.d. |
Test substance |
5 |
5000 |
553.0 ± 68.9 |
582.2 ± 26.1 |
2.80 ± 1.10 |
2.20 ± 1.30 |
n.d. = not determined
Table 2: Results of the in vivo micronucleus assay in female animals
|
Mean PCEs / 1000 NCEs at sampling time |
Total micronuclei per 1000 PCEs at sampling time |
||||
Group |
Number of animals |
Dose [mg/kg bw] |
24 h |
48 h |
24 h |
48 h |
Vehicle control I (corn oil) |
5 |
0 |
578.6 ± 39.9 |
n.d. |
2.40 ± 1.14 |
n.d. |
Vehicle control II (corn oil) |
5 |
0 |
557.6 ± 61.6 |
n.d. |
2.40 ± 2.70 |
n.d. |
Positive control (cyclophosphamide) |
5 |
40 |
557.8 ± 73.6 |
n.d. |
29.2 ± 11.9 |
n.d. |
Test substance |
5 |
500 |
584.8 ± 70.6 |
n.d. |
1.0 ± 1.41 |
n.d. |
Test substance |
5 |
1500 |
618.6 ± 45.7 |
n.d. |
2.20 ± 1.64 |
n.d. |
Test substance |
5 |
5000 |
549.6 ± 88.6 |
526.4 ± 59.4 |
1.0 ± 0.71 |
2.20 ± 1.30 |
n.d. = not determined
Table 3: PCE/NCE ratio males and females
Treatment group |
Dose [mg/kg] |
Sampling time [h] |
PCE/NCE ratio |
Vehicle control I (corn oil) |
0 |
24 |
1.20 ± 0.29 |
Vehicle control II (corn oil) |
0 |
24 |
1.19 ± 0.35 |
Test substance |
500 |
24 |
1.40 ± 0.50 |
Test substance |
1500 |
24 |
1.46 ± 0.46 |
Test substance |
5000 |
24 |
1.29 ± 0.39 |
Test substance |
5000 |
48 |
1.27 ± 0.24 |
Positive control (Cyclophosphamide) |
40 |
24 |
1.24 ± 0.53 |
Table 4: Historical data, vehicle controls
Parameter |
Mean |
Normal range |
Number of polychromatic erythrocytes with micronuclei per 1000 polychromatic erythrocytes |
|
|
Male |
1.95 ± 1.02 |
< 3.99 |
Female |
1.98 ± 0.76 |
< 3.50 |
Male and female |
- |
|
Ratio of polychromatic to normochromatic erythrocytes (1000) |
|
|
Male |
1.12 ± 0.34 |
0.44 - 1.88 |
Female |
1.13 ± 0.20 |
0.73 - 1.53 |
Male and female |
1.13 ± 0.27 |
0.59 - 1.67 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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