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Diss Factsheets
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EC number: 943-109-7 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- other: OF-1 albino mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight: male/female 25g
Supplier: from a SPF colny IFFA-CREDO, L'Arbresie France
Quarantine period of 1 week, the animals were allowed a libitum access to food (Aliment Rats-Souris Charles River, produced by U.A.R, Villemoisson/Orge France) and drinking water.
Animals were housed 5 of the same sex per cage in Makrolon type III cages. - Route of administration:
- oral: gavage
- Vehicle:
- deionised water
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 1 500 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
1500 mg/kg bw - No. of animals per sex per dose:
- 5 mice / sex / Group
- Control animals:
- yes, concurrent vehicle
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- At low magnification of the microscope no neticeable differences in bone marros nucleated cells were observed between tested animals and negative control.
In the positive control group (Thio-TEPA) decreased numbers of nucleated bone marrow cells were noted.
There was no statistically significant increase in the number of micronucleated polychromatic erythrocytes in animals exposed to 500 mg/kg of the tested substance compared to negative controls. In animals treated with positive control there was a statistically significant increased number of micronucleated cells.
The ration of polychromatic to normochromatic erythrocytes was markedly decreased in mice treated with positive control. There is no difference between animals treated with the tested substance and the negative control for this ratio. - Conclusions:
- In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore the tested substance is considered to be non-mutagenic in this micronucleus assay.
- Executive summary:
The tested substance is considered to be non-mutagenic in this micronucleus assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Both in vitro and in vivo mutagenicity tests are available for the tested substance.
The results of the in vitro ames and in vitro chromosome aberration test, made are both negative.
In addiction also the in vivo micronucleus (bone marrow) test showed negative results.
Based on these tests, the tested substance could be considered as not mutagenic.
Short description of key
information:
Not mutagenic
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.
For the purpose of classification for germ cell mutagenicity, substances are classified if there is at least positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
- somatic cell mutagenicity tests in vivo, in mammals; or
- other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
The presented results from in vivo and the in vitro tests are negative, therefore it is concluded that the tested substance is not genotoxic with or without metabolic activation.
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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