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EC number: 218-216-0 | CAS number: 2082-79-3
- 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 / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline, without GLP (acceptable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- limited documentation (no evaluation criteria reported)
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Cricetulus griseus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male 27-38 g, female 23-30 g
- Diet (e.g. ad libitum): Standard diet, NAFAG No.924
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Concentration of test material in vehicle: 2 %
- Amount of vehicle (if gavage or dermal): 20 ml/kg bw - Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Doses / concentrations: 64 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Based on the Lab results (PH 2.634, dated March 11, 1975), the oral LD was found to be >6000 mg/kg bw in Chinese hamster of either sex.
TREATMENT AND SAMPLING TIMES:
The treated groups consisted of four female and four male animals each. The control groups consisted of six female and six male animals each. The substance was administered orally once daily on 2 consecutive days. The animals were injected intraperitoneally with 10 mg colcemide/kg 2 h after the second dose and sacrificed 4 h later.
METHOD OF ANALYSIS:
Four animals (two females and two males) from each group treated with the various doses of the test article and from the negative and from the positive control group each were analysed by reference to the following criteria:
- Chromatid-type aberrations
- Chromosome-type aberrations
- Chromatid gaps
- Chromosome pulverizations
100 metaphases were analysed per animal. - Evaluation criteria:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- In the low-dose group one metaphase (out of 400 metaphases) was found showing a chromatid-type aberration in the form of a break. The chromosome displays from animals of the intermediate-dose, of the high-dose and of the control group showed no aberrations.
- In contrast to the test substance, cyclophosphamide, 64 mg/kg bw used as positive control caused an increase in all types of aberrations (chromatid-type aberrations 22.0%; chromosome-type aberrations 0.25%). The difference is highly significant (p<0.05).
Any other information on results incl. tables
The Effect of TK10044 and Cyclophosphamide on Bone Marrow Cells of Chinese Hamster
Parameters |
Control |
Cyclophosphamide |
Irganoc 1076 (mg/kg bw) |
||
2% CMC |
64 mg/kg bw |
500 |
1000 |
2000 |
|
Percent of metaphases with specific aberrations |
0 |
22 |
0 |
0 |
0 |
Chromatid-type aberrations (mean) |
0 |
22 |
0.25 |
0 |
0 |
Chromosome-type aberrations (mean) |
0 |
0.25 |
0 |
0
|
0 |
Chromatid gaps (mean) |
2.25 |
17.5 |
2.5 |
2.75 |
2.25 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It can be concluded from the results that the test substance exerted no mutagenic action in the Chinese hamster under the experimental conditions.
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