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EC number: 288-306-2 | CAS number: 85711-46-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read across substance, well documented, according to GLP and OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
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 substance name:
- 1309959-24-7
- Cas Number:
- 1309959-24-7
- IUPAC Name:
- 1309959-24-7
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 35.5g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 30% DMSO / 70% PEG 400
The vehicle was chosen due to its relative nontoxicity for the animals. - Details on exposure:
- Heating (max. 90 °C) will be performed during formulation, for administration the formulation will be kept at body temperature.
- Duration of treatment / exposure:
- 24h and 48h
- Frequency of treatment:
- single
- Post exposure period:
- 24h treatment:
negative control: 1-5h
low dose: 6-12h
medium dose: 13-19h
high dose: 20-26h
positive control: 27-31h
48h treatment:
negative control: 32-36h
positive control: 37-43h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
500, 1000, and 2000 mg/kg bw
Basis:
actual ingested
24h preparation interval
- Remarks:
- Doses / Concentrations:
200 mg/kg bw
Basis:
actual ingested
48h preparation interval
- No. of animals per sex per dose:
- 7 / test group, 5 for vehicle and positive control group,
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Name: Cyclophosphamide (CPA)
Supplier: Fisher Scientific GmbH
61130 Nidderau, Germany
Dissolved in: sterile water
Dosing: 40 mg/kg b.w.
Route and frequency
of administration: orally, once
Volume administered: 10 mL/kg b.w.
Examinations
- Tissues and cell types examined:
- bone marrow derived erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
DETAILS OF SLIDE PREPARATION:
The animals will be sacrificed using CO2 followed by bleeding. The femora are removed, the epiphyses are cut off and the marrow is flushed out with foetal calf serum, using a syringe. The cell suspension is centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant is discarded. A small drop of the resuspended cell pellet is spread on a slide. The smear is air-dried and then stained with May-Grünwald/Giemsa. Cover slips are mounted with EUKITT. At least one slide is made from each bone marrow sample.
METHOD OF ANALYSIS:
Evaluation of the slides is performed using NIKON microscopes with 100x oil immersion objectives. At least 2000 polychromatic erythrocytes (PCE) are analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes is determined in the same sample and expressed in polychromatic erythrocytes per 2000 erythrocytes. The analysis is performed with coded slides.
All surviving animals per test group will be evaluated as described. - Evaluation criteria:
- A test item is classified as mutagenic if it induces either a dose-related increase or a clear increase in the number of micronucleated polychromatic erythrocytes in a single dose group. Statistical methods (nonparametric Mann-Whitney test (8), p < 0.5) will be used as an aid in evaluating the results, if necessary. The vehicle control group of the respective time point will be used as reference. However, the primary point of consideration is the biological relevance of the results. A test item that fails to produce a biological relevant increase in the number of micronucleated polychromatic erythrocytes is considered non-mutagenic in this system.
- Statistics:
- Statistical methods (nonparametric Mann-Whitney test (8), p < 0.5) will be used as an aid in evaluating the results, if necessary.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: up to 200 mg/kg bw, 24h and 48h, 2animals /sex/dose
- Clinical signs of toxicity in test animals: no
- Rationale for exposure: limit dose
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): negative
- Ratio of PCE/NCE (for Micronucleus assay): uneffected
- Statistical evaluation: non-parametric Mann-Whitney test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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.
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