Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 461-290-6 | CAS number: 167374-38-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP regulations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): MEOE
- Analytical purity: 96% ± 1 (see analytical report 061L00055)
- Test substance No.: 04/0450-2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany GmbH
- Age at study initiation: 5-8 weeks
- Weight at study initiation: about 30 g (mean)
- Housing: Single in Makrolon cages, type MI
- Diet (e.g. ad libitum): Standard ized pelleted feed, Provimi Kliba SA, Kaiseraugst, Switzerland
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: corn oil
- Justification for choice of solvent/vehicle: Due to the good suspensibility of the test substance in corn oil, corn oil was selected as the vehicle, which had been demonstrated to be suitable in the in vivo micronucleus test and for which historical data are available. - Duration of treatment / exposure:
- 24 hours for 500 and 1000 mg/kg bw doses
24 and 48 hours for the 2000 mg/kg bw dose - Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- Cyclohexylamine (CPP) 20 mg/kg bw for clastogenic effects
Vincristine Sulphate (VCR) 0.15 mg/kg bw dor aneugenic effects
both dissolved in purified water.
- Justification for choice of positive control(s): The stability of CPP and VCR is welI-defined under the selected conditions, since both
positive control articles are well-established reference clastogens and aneugens respectively.
- Route of administration: orally in a volume of 10 mL/kg bw.
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes (PCE) in the bone marrow.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
In a pretest for the determination of the acute oral toxicity, at 2 000 mg/kg bw recommended as the highest dose according to the OECD Guideline all animals (male and female) survived. The clinical signs only observed were squatting posture and soft feces. However, there were no distinct differences in the symptoms between males and females. Thus, only male animals were used for the cytogenetic investigations.
TREATMENT AND SAMPLING TIMES:
The animais were treated once and samples of bone marrow were taken 24 hours and 48 hours after the treatment.
DETAILS OF SLIDE PREPARATION:
The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum. The cell suspension was centrifuged at 300 x g for 5 minutes and the supernatant was discarded. A drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald/Giemsa. Cover slips were mounted in Corbit-Balsam.
METHOD OF ANALYSIS:
In general, 2000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei (MN). To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in normochromatic erythrocytes per 2000 PCEs . The analysis was performed with coded slides. - Evaluation criteria:
- A Test substance is considered positive if the following criteria are met:
- Significant and dose-related increase in the number of PCEs containing micronuclei.
- The number of PCEs containing micronuclei has to exceed both the concurrent negative control and the highest value of the historical control range.
A test substance is considered negative if the following criteria are met:
- The number of cells containing micronuclei in the dose groups is not significantly above the negative control and is within the historical control data - Statistics:
- The statistical evaluation of the data was carried out using the program system MUKERN (BASF AG).
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
The single oral administration of corn oil in a volume of 20 mL/kg body weight led to 0.9‰ polychromatic erythrocytes containing micronuclei after the 24-hour sacrifice interval or to 1.5‰ after the 48-hour sacrifice interval.
After the single administration of the highest dose of 2000 mg/kg body weight, 1.0‰ polychromatic erythrocytes containing micronuclei were found after each 24 hours and 48 hours.
In the two lower dose groups, rates of micronuclei of about 1.5‰ (1000 mg/kg group) and 1.7‰ (500 mg/kg group) were detected after a sacrifice interval of 24 hours in each case.
With 27.2‰ the positive control substance cyclophosphamide for clastogenicity, as expected, led to a clear increase in the number of polychromatic erythrocytes containing exclusively small micronuclei.
Vincristine, a spindle poison agent, produced a 43.6‰ increase in micronuclei in polychromatic erythrocytes. A significant portion increase, 11.1‰ was attributable to large micronuclei.
The number of normochromatic erythrocytes containing micronuclei did not differ to any appreciable extent in the negative control or in the various dose groups at any of the sacrifice intervals.
No inhibition of erythropoiesis induced by the treatment of mice with MEOE was detected at any doses; the ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.