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EC number: 470-280-0 | 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:
- key study
- Study period:
- 09 October 2007 - 05 December 2007
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- SPP100 B7
- IUPAC Name:
- SPP100 B7
- Reference substance name:
- 325740-68-9
- Cas Number:
- 325740-68-9
- IUPAC Name:
- 325740-68-9
- Details on test material:
- - Name of test material (as cited in study report): SPP100 B7
- Chemical name: Methanesulfonic Acid (1R, 3S)-1-((2S,4S)-4-Isopropyl-5-Oxotetrahydro-furan-2YI)-3-[4-methoxy-3-(3-methoxy-propoxy)-benzyl]-4-methyl-pentyl ester (solution)
- Molecular formula (if other than submission substance): C26H42O8S
- Molecular weight (if other than submission substance): 514.67
- Physical state: Highly viscous oil
- Analytical purity: 94.9%
- Impurities (identity and concentrations): 0.7% - toluen
- Lot/batch No.: C0031
- Expiration date of the lot/batch: December 2007
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature
- Other: stable in water
- Solubility in water: 0.011g/l
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutchland GmbH, Sulzfeld
- Age at study initiation: 9 weeks
- Weight at study initiation: males 30.9 - 39.7, females 30.0 - 38.4
- Assigned to test groups randomly: yes
- Housing: Makrolon cages with aspen wood chips as bedding material. Males - single caging, females - five animals per cage.
- Diet (e.g. ad libitum): at libitum
- Water (e.g. ad libitum): at libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 - 23
- Humidity (%): 36.4 - 68.5
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: according to the sponsor the test substance is very poorly soluble in water. Corn oil is a common vehicle for oral toxicity testing.
- Amount of vehicle (if gavage or dermal): 5 ml/kg body weight - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test substance was heated and then appropriate amounts were blended with corn oil. All formulations were prepared withing a maximumum of 70 minutes before administrations.
DIET PREPARATION
- Rate of preparation of diet (frequency): once - Duration of treatment / exposure:
- Negative control and high dose: 24 and 48 hours
Low, mid dose and positive control: 24 hours - Frequency of treatment:
- once
- Post exposure period:
- none
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1500 mg/kg body weight
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2000 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males and 5 females per group per sampling
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none; cyclophosphamide monohydrate, SIGMA No C-0768, CAS No. 6055-19-2
- Justification for choice of positive control(s): Recommended by the guidelines
- Route of administration: oral gavage
- Doses / concentrations: 40 mg/kg body mass
- Dose volume 10 ml/kg body mass
Examinations
- Tissues and cell types examined:
- bone marrow smears
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: In a 28-days toxicity study 1000 mg/kg body mass was tolerated by rats without any mortality.
DETAILS OF SLIDE PREPARATION: Bone marrow was obtained from both femurs and was prepared according to the method of W. Schmid. For each animal three smears were prepared. Two of them were stained using a slightly modified Pappenheim method, coded and scored.
METHOD OF ANALYSIS:
Composition of bone marrow:
For each slide the ratio of nucleated cells to erythrocytes was determined by counting at least 200 cells per slide, i.e. at least 400 per animal. The ratio of polychromatic to normochromatic erythrocytes was determined by counting at least 500 erythrocytes per slide.
Micronucleated erythrocytes:
2000 polychromatic erythrocytes per animal were counted. The number of polychromatic erythrocytes with one or more micronuclei was recorded. When counting erythrocytes for the evaluation of the ratio polychromatic to normchromatic erythrocytes the number of normchromatic erythrocytes with one or more micronuclei was recorded, too. - Evaluation criteria:
- No data
- Statistics:
- P=0.05 was chosen in each test.
Micronucleated cells:
U-test of Wilcoxon, Mann and Whitney: for comparison of two groups.
H-test of Kruskal and Wallis followed by the test of Nemenyi: for comparison of more than two groups.
Body masses, composition of bone marrow
t-test: for comparison of two groups.
Analysis of variance followed by the Scheffé test: for comparison of more than two groups.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 1000, 1500 and 2000 mg/kg body mass
- Solubility: in water: 0.011g/l, soluble in warm corn oil
- Clinical signs of toxicity in test animals: none
- Evidence of cytotoxicity in tissue analyzed: none
- Rationale for exposure: maximum allowed dose
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no statistically significant differences in the amounts of micronucleated normochromatic erythrocytes between the test substance group animals and the negative controls.
- Ratio of PCE/NCE (for Micronucleus assay): There was no marked or statistically significant increases in the micronucleated polychromatic erythrocytes in the test substance group animals and all dosage groups compared to the corresponding negative controls 24 and 48 hours after administration and neither at doses of 1000, 1500 or 2000 mg/kg body mass.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Cyclophosphamide produced micronuclei in polychromatic erythrocytes, thus demonstrating the sensitivity of the test system used for the endpoints investigated in this study.
SPP100 B7 did not produce relevant increase of the numbers of micronuclei in polychromatic erythrocytes in animals of the test species at doses of 1000, 1500 or 2000 mg/kg body mass and sampling times of 24 and 48 hours p.a..
No cytotoxicity was noted at any tested dose 24 and 48 hours after the administration of the test substance at any dose administered.
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