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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 479-540-8 | CAS number: 61007-89-4
- 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:
- 13.01. - 10.02.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted on July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 479-540-8
- EC Name:
- -
- Cas Number:
- 61007-89-4
- Molecular formula:
- C27 H27 Mn N4 O3
- IUPAC Name:
- manganese(3+) 2-[({2-[bis(2-{[(2-oxidophenyl)methylidene]amino}ethyl)amino]ethyl}imino)methyl]benzen-1-olate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Biotechnology and Animal Breeding Division, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation:
males mean value: 32.7 +/- 3.1 g; 26.2 g +/- 3.0 g
- Housing: individually in Makrolon type I cages
- Diet: standard pelleted laboratory animal diet, ad libitum; food was withheld 18 hrs before treatment
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 20-70%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle used: Corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test substance was formulated in corn oil. - Duration of treatment / exposure:
- Single treatment.
- Frequency of treatment:
- The animals received the test item, the vehicle or the positive control substance once each preparation interval.The dosing volume was 10 mL/kg bw.
- Post exposure period:
- 24 or 48 hrs
Doses / concentrations
- Remarks:
- Doses / Concentrations:
24 h preparation interval: 500, 1000, and 2000 mg/kg bw. and 48 h preparation interval: 2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 NMRI mice for the 24-hour sampling (all dose groups), 3 NMRI mice for the 48-hour sampling (high dose group only)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow smears from femur; erythrocytes (poly- and normochromatic)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The maximum treated dose of 2000 mg/kg bw was used as the high dose. Lower levels were spaced by a factor of 2.
TREATMENT AND SAMPLING TIMES
The animals dosed with corn oil and the test substance were sacrificed by cervical dislocation 24 or 48 h after the second dosing. The animals treated with cyclophosphamide were sacrificed by cervical dislocation 48 hr after dosing. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant was discarded.
DETAILS OF SLIDE PREPARATION:
A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald. Cover slips were mounted with EUKITT. At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS:
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. At least 2000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and total erythrocytes was determined in the same sample and expressed in polychromatic erythrocytes per 2000 erythrocytes. The analysis was performed with coded slides. Ten animals (5 males, 5 females) per test group were evaluated as described. - Evaluation criteria:
- A test substance is considered positive in the micronucleus test if:
It induced a biologically as well as a statistically significant (Wilcoxon Rank Sum Test; two-sided test at P < 0.05) increase in the frequency of micronucleated polychromatic erythrocytes (at any dose or at any sampling time).
A test substance is considered negative in the micronucleus test if:
None of the tested concentrations or sampling times showed a statistically significant (P < 0.05) increase in the incidence of micronucleated polychromatic erythrocytes.
The study was considered valid as the following criteria are met:
- the negative controls are in the range of the historical control data (0.01 - 0.15 %; mean = 0.066 ± 0.032 PCEs with micronuclei).
- the positive controls are in the range of the historical control data (0.91 - 2.975 %; mean = 1.644 ± 0.446 PCEs with micronuclei).
- at least 80 % of animals are evaluable - Statistics:
- Statistical significance at the 5 % level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
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 RANGE-FINDING STUDY
- Dose range: between 500 and 2000 mg/kg bw (the maximum guideline-recommended dose) was suitable.
- Solubility: soluble in corn oil
- Clinical signs of toxicity in test animals: no
- Evidence of cytotoxicity in tissue analyzed: no
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used.
- Ratio of PCE/NCE (for Micronucleus assay): After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control thus indicating that the test item did not exert any cytotoxic effects in the bone marrow.
- Appropriateness of dose levels and route: yes
- Statistical evaluation: No statistically significant differences in the frequency of erythrocytes containing micronuclei between the solvent control and the dose groups was observed.
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.