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Diss Factsheets
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EC number: 240-347-7 | CAS number: 16219-75-3
- 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
In vitro Studies
ENB has been investigated in in vitro tests, and did not induce gene mutation in bacterial systems or chromosomal aberration in mammalian cultured cells, with or without an exogenous metabolic activation system. Several well conducted and reported studies were identified.
Reverse gene mutation assay was conducted by OECD TG 471 and TG 472. The substance was not mutagenic in Salmonella typhimuriumTA100, TA1535, TA98, TA1537 and Escherichia coliWP2uvrA at concentration of ranging from 0.00781 to 0.25 mg /plate, with and without an exogenous metabolic activation system (MHW, Japan, 1998). ENB was not mutagenic in Salmonella typhimuriumstrains TA100, TA1535, TA98, TA1537 and TA1538 at concentrations of 0.001 to 0.1 mg/plate (Ballantyne, 1998).
Chromosomal aberration test by OECD TG 473 was conducted in cultured Chinese hamster lung (CHL/IU) cells. Structural chromosomal aberrations and polyploidy were not induced up to a maximum concentration of 0.050 mg/mL on continuous treatment, and 0.1 mg/ml on short-term treatment, with and without an exogenous metabolic activation systems, respectively (MHW, Japan, 1998). ENB at concentrations ranging from 0.006 to 0.06 mg/mL did not produce increases in chromosome aberrations in Chinese hamster ovary (CHO) cells with or without metabolic activation (Ballantyne, 1998). ENB was not mutagenic in the CHO/HGPRT forward gene mutation assay at concentrations of 0.02 to 0.08 mg/mL (without activation) and 0.02 to 0.10 mg/mL (with activation), and was not mutagenic in the sister chromatid exchange test at concentration of 0.01 to 0.06 mg/mL with and without metabolic activation (Ballantyne, 1998).
In vivo Studies
The rat dominant lethal test showed a no-observed effect concentration for dominant lethality greater than 254 ppm ENB (Neeper-Bradley and Ballantyne, 1996). There are no other available data on genotoxicity in vivo.
Short description of key information:
ENB was not mutagenic with and without an exogenous metabolic activation system in bacteria and mammalian cells in vitro [OECD TG 471, 472, 473]. The chemical induced neither chromosomal aberrations nor sister chromatid exchanges in mammalian cells in culture. It also did not induce dominant lethal mutation in rats.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
On the basis of reliable negative studies (in vitro mutation, chromosome abberations and SCE; in vivo dominant lethal), no classification is proposed.
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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