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EC number: - | 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
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985-07-08 until 1985-08-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: micronucleus assay
Test material
- Reference substance name:
- Oleic methyl ester, epoxidized, reaction products with glycerol
- IUPAC Name:
- Oleic methyl ester, epoxidized, reaction products with glycerol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: LA 990
- Substance type: organic
- Physical state: viscous liquid, beige-coloured
- Lot/batch No.: 37-4-222
- Stability under test conditions: stable under test conditions
- Storage condition of test material: at room temperature
Test animals
- Species:
- mouse
- Strain:
- other: CWF 1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, 4799 Borchen, FRG
- Age at study initiation: appox. 8 weeks
- Weight at study initiation: 17 -30 g
- Housing: Male mice individually in macrolon cages type I; female mice up to 4 animals per cage in macrolon cages type II.
- Diet: Altromin No. 1324, 10 mm pellet diameter, supplied from Altrogge Spezialfutter.
- Water: Drinking water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours dark/ light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: distilled water with carboxymethyl cellulose 2% and cremophore 0.5 %
- Justification for choice of vehicle: preparation of a suspension for adequate administration
- Amount of vehicle: 20 mL/kg - Frequency of treatment:
- once
- Post exposure period:
- 10000 mg/kg bw: 24, 48, and 72 h
5000 mg/kg bw: 24 h
1000 mg/kg bw: 24 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 10 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 7 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamid 10 mg/kg bw intraperitoneal (seven male and female animals)
Examinations
- Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:
24, 48 and 72 h after the administration the animals were sacrificed with an overdose of carbonmonoxide. Bone marrow was extracted from the femur and prepared adequately. Three slides were prepared for each animal. The slides were air-dried at least overnight and then stained with Giemsa according to modification of Gollapudi and Kamra. The slides were fixed in 100 % methanol for 5 min., then rinsed twice in distilled water and thereafter stained in Giemsa solution. After air -drying the back side was cleaned, necessary with ethanol and then dipped for 3 min. in xylol.
METHOD OF ANALYSIS:
From the three slides prepared per animal, one slide was chosen and randomly scored. The slides of five male and five female animals per treatment group were scored microscopically at a magnification of 1000. The number of micronucleated cells was counted in 1000 polychromatic erythrocytes/ per animal. The ratio of polychromatic to normochromatic erythrocytes was determined by counting and differentiating the first 1000 erythrocytes at the same time. Averages and standard deviations were calculated after decoding the complete scoring results. - Evaluation criteria:
- - A micronucleus test is considered acceptable if it meets the following criteria: The positive control substance induced a statistical significant increase in the frequency of micronucleated polychromatic erythrocytes - the incidence of micronuclei should reasonably fall within the historical control data range of the laboratory.
- A test item is considered positive in the micronucleus test if it induced a biologically as well as statistically significant increase (p < 0.05) in the frequency of micronuclei at any dose or at any sampling either in the male or in the female groups.
- A test substance is considered negative in the micronucleus test if none of the tested doses or sampling times showed a statistically significant (p < 0.05) increase in the incidence of micronuclei, neither in male nor in female groups. - Statistics:
- Statistical analysis of data was performed by calculating the statistical significance versus negative controls with the aid of the tables of Kastenbaum and Bowman. The preceding criteria are not absolute and other factors may influence the final evaluation decision.
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 DEFINITIVE STUDY
At the highest test item concentration of 10000 mg/kg bw, no effect on the numerical ratio between polychromatic and normchromatic erythrocytes was observed. Furthermore, the test item did not cause a significantly elevated number of micronucleated polychromatic erythrocytes when compared to the concurrent negative control. Thus the lower test item concentrations of 5000 and 1000 mg/kg bw were not microscopically evaluated. Besides the death of one animal in the 5000 mg/kg bw does group, not toxic effects were observed. The death of this animal could not be related to the test item exposure.
Applicant's summary and conclusion
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