Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 203-703-2 | CAS number: 109-77-3
- 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
Additional information
Ames-Test:
The test material showed toxic efficacy in the presence and in the absence of metabolic activation at the concentration of 5000 MCG per plate, so that an evaluation of the potential mutagenic activity was prevented at this dose.
Up to the highest evaluted dose 1580 MCG per plate +/- activation system, no relevant increase of the revertant colony numbers was obtained in any strain in comparison with the corresponding controls.
In conclusion, no gene mutagenic activity could be demonstrated under the experimental conditions.
CA-Test:
The test compound dose levels for analysis were selected by determining mitotic indices from a broad range of doses up to 5000 MCG/ml.
It is concluded that Malononitrile was able to induce chromosome aberrations in cultured human lymphocytes both in the absence and presence of S-9 when tested to its limit of toxicity.
Micronucleus-Test:
Malononitrile did not induce chromosomal or other damage leading to micronucleus formation in polychromatic erythrocytes in the bone marrow of mice treated once by the oral route and killed 24, 48 or 72 hours later.
The test procedure was highly sensitive to the chromosome-damaging action of chlorambucil.
Short description of key information:
Ames test (in vitro): according to OECD 471
Salmonella Thyphimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538
With and without liver microsomal activation
Eight concentration: 1.58 / 5 / 15.8 / 50 / 158 / 500 / 1580 and 5000 MCG per plate, each compound concentration including controls was tested in triplicate.
CA-test (in vitro): according to OECD 473
Malononitrile was tested in an in vitro cytogenetics assay using duplicate human lymphocyte cultures from a single male donor. +/- metabolic activation by a rat liver postmitochondrial fraction (S-9) from Aroclor-1254 induced animals.
Micronucleus-Test (in vivo): according to OECD 474
The effect of Malononitrile on chromosome structure in bone marrow cells was investigated following acute oral administration to mice. Chromosome damage was measured indirectly by counting micronucle.
Dose: 2.5, 5, 10 and 20 mg/kg
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Ames-test - negative
CA-test - positive
Micronucleus-test - negative
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