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EC number: 271-363-2 | CAS number: 68551-11-1 A complex combination of products produced by the distillation of products from the hydrogenation of butanal from the hydroformylation of propene. It consists predominantly of organic compounds such as aldehydes, alcohols, esters, ethers and carboxylic acids having carbon numbers in the range of C4-C32 and boiling in the range of approximately 143°C to 282°C (289°F to 540°F).
- 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: GLP guideline study (OECD guideline 474).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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): EP202
- Physical state: Liquid, colorless, clear
- Analytical purity: The test substance is a mixture containing different components.
- Composition of test material, percentage of components:
- Test substance No.: 06/0723-1
- Batch identification: F701501mH
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period is guaranteed.
- Storage condition of test material: Room temperature
Test animals
- Species:
- mouse
- Strain:
- other: Crl:NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: mean: 30.1 g
- Assigned to test groups randomly: yes, under following basis: appropriate computer program
- Housing: single
- Diet: Standardized pelleted feed
- Water: ad libitum
- 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 solubility of the test substance in corn oil, corn oil was used as vehicle. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All test substance formulations were prepared immediately before administration.
- Duration of treatment / exposure:
- 48 h (test substance), 24 h (positive controls)
- Frequency of treatment:
- twice with a 24-hour interval between both administrations (the positive controls were administered only once)
- Post exposure period:
- 24 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000, 2000 mg/kg bw (10 mL solution/kg bw)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 male animals per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide; vincristine
- Justification for choice of positive control(s): The stability of cyclophophamide and vincristin is well-defined under the selected conditions, since both substances are well-established reference clastogens and aneugens, respectively.
- Route of administration: cyclophosphamide: oral administration, vincristine: intraperitoneal administration
- Doses / concentrations: cyclophosphamide: 20 mg/kg bw, vincristine: 0.15 mg/kg bw
Examinations
- Tissues and cell types examined:
- 2000 polychromatic erythrocytes were evaluated per animal and investigated for micronuclei. The normocytes with and without micronuclei occurring per 2000 polychromatic erythrocytes were also recorded.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The test doses were selected on the basis of the non-GLP range finding part of the study (see Additional informations on results).
DETAILS OF SLIDE PREPARATION: The bone marrow was prepared according to the method described by Schmid (1976, The micronucleus test for cytogenetic analysis, Hollaender, A. (ed), Chemical Mutagens, Principles and Methods for their Detection, Volume 4, Plenum Press, New York; 1977, The micronucleus test, Kilbey et al. (eds), Handbook of Mutagenicity Test Procedures, Elsevier Scientific Publishing Company, Amsterdam - New York - Oxford) and Salamone et al (1980, Towards an improved micronucleus test. Studies on 3 model agents, mitomycin C, cyclophosphamide and dimethylbenzanthracene. Mut. Res., 74, 347 - 356). The slides were stained with eosin and methylene blue (modified May-Gruenwald solution or Wrights solution). After briefly rinsing in purified water, the preparations were soaked in purified water. Subsequently, the slides were stained with Giemsa solution. After rinsing twice in purified water and clarifying in xylene, the preparations were mounted in Corbit-Balsam.
- Evaluation criteria:
- The mouse micronucleus test is considered valid if the following criteria are met: - The quality of the slides must allow the evaluation of a sufficient number of analyzable cells; i. e. ≥ 2000 PCEs per animal and a clear differentiation between PCEs and NCEs; - The ratio of PCEs/NCEs in the concurrent vehicle control animals has to be within the normal range for the animal strain selected; - The number of cells containing micronuclei in vehicle control animals has to be within the range of the historical negative control data both for PCEs and for NCEs; - The two positive control substances have to induce a distinct increase in the number of PCEs containing small and/or large micronuclei within the range of the historical positive control data or above;
A finding is considered positive if the following criteria are met: - Statistically significant and dose-related increase in the number of PCEs containing
micronuclei; - The number of PCEs containing micronuclei has to exceed both the concurrent vehicle control value and the range of the historical negative control data;
A test substance is considered negative if the following criteria are met: - The number of cells containing micronuclei in the dose groups is not statistically significant increased above the concurrent vehicle control value and is within the range of the historical negative control data. - Statistics:
- The statistical evaluation of the data was carried out using the program system MUKERN (BASF AG). The asymptotic U test according to MANN-WHITNEY (modified rank test according to WILCOXON) was carried out to clarify the question whether there are statistically significant differences between the untreated control group and the treated dose groups with regard to the micronucleus rate in polychromatic erythrocytes. The relative frequencies of cells containing micronuclei of each animal were used as a criterion for the rank determination for the U test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- (The administration of 2000 mg/kg bw of the test substance led to distinct clinical signs of toxicity (squatting posture, staggering: 1-2 h after the administrations).)
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 2000 mg/kg bw (two treatments) was recommended as the highest dose according to the OECD guideline.
- Clinical signs of toxicity in test animals: All animals (male and female) survived. The clinical signs observed were hunched posture and staggering within one hour after administration only. However, there were no distinct differences in the symptoms between males and females (Thus, only male animals and a dose of 2000 mg/kg bw were selected as the highest dose in the present cytogenetic study. 1000 mg/kg and 500 mg/kg bw were administered as further doses)
RESULTS OF DEFINITIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): An inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected at the top dose of 2000 mg/kg bw.
Any other information on results incl. tables
Substance | Dose (mg/kg) | sacrifice interval [h] | Micronuclei in PCE | Number of NCEc | |
total [‰]a | large MN [‰]b | ||||
vehicle | solvent | 24* | 0.9 | 0.0 | 3678 |
test substance | 500 | 24* | 0.9 | 0.0 | 4287 |
test substance | 1000 | 24* | 1.1 | 0.0 | 4365 |
test substance | 2000 | 24* | 1.2 | 0.0 | 5952 |
positive ctrl | 20 | 24** | 9.7# | 0.0 | 3127 |
positive ctrl | 0.15 | 24** | 48.6# | 12.5# | 6513 |
* twice administration: sacrifice 24 hrs after 2nd administration, respectively 48 hrs after 1st administration | |||||
** single administration: sacrifice 24 hrs after administration | |||||
# p</= 0.01 | |||||
PCE = polychromatic erythrocyts (2000 were scored for micronuclei) | |||||
NCE = normochromatic erythrocyts | |||||
a: sum of small and large micronuclei | |||||
b: large micronuclei (indication for spindle poison effect) | |||||
c: number of NCEs observed when scoring 10000 PCEs |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the experimental conditions chosen here, the test substance EP202 does not have any chromosome-damaging (clastogenic) effect, and there were no indications of any
impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells in vivo. - Executive summary:
EP202 was administered to male Crl:NMRI mice (5 mice/dose). The study is reliable. Under the experimental conditions chosen here, the test substance EP202 does not have any chromosome-damaging (clastogenic) effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells in vivo.
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