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EC number: 250-001-7 | CAS number: 30007-47-7
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Study period:
- The assessment was conducted in April 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requ irements of Annex VIII (8.8).
Data source
Reference
- Reference Type:
- other:
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been
conducted to the extent that can be derived from the relevant available information.The assessment
is based on the Guidance on information requirements and chemical safety assessment R.7c:
Endpoint specific guidance (ECHA, November 2014) - GLP compliance:
- no
- Remarks:
- Not relevant for assessment
Test material
- Reference substance name:
- 5-bromo-5-nitro-1,3-dioxane
- EC Number:
- 250-001-7
- EC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Cas Number:
- 30007-47-7
- Molecular formula:
- C4H6BrNO4
- IUPAC Name:
- 5-bromo-5-nitro-1,3-dioxane
- Details on test material:
- - Chemical name: 5-Brom-5-nitro- 1,3-dioxan
- Trade name: Bronidox
Constituent 1
- Specific details on test material used for the study:
- Identification: 5-Bromo-5-nitro-1,3-dioxane
Batch (Lot) Number: 201807021
Expiry date: 30 Jun 2020 (expiry date) (taken from label)
Physical Description: White crystal powder
Storage Conditions: At room temperature - Radiolabelling:
- no
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
TOXICOKINETIC BEHAVIOUR
The substance is a white colored powder with physico-chemical properties (Particle size: MMAD= 438µm; Vapor Pressure: 1.6 Pa at 20 ºC)
which imply the risk ofparticle inhalation to be minimal. Furthermore, the supporting toxicological information suggests
any inadvertent inhalation is unlikely to lead to an elevation in systemic toxicity. The substance was identified to
be an ocular irritant with potential for severe damage in the BCOP assay; the in vitro genotoxicity panel indicates that
there are concerns for genotoxicity, with a psoitive result observed in the mouse lymphoma assay, subject to confirmatory in vivo testing.
The results from a dermal corrosivity study, in conjunction with the molecular weight (211 g/mol) and log
Pow (1.6) indicate significant absorption might occur via the dermis. Acute oral toxicity results showed the
LD50 to be ~500 mg/kg body weight, additionally the Oral (Gavage) Repeated Dose Toxicity Study in the
rat resulted in hepatic effects resulting in death at the highest dose, indicating gasto-intestinal absorption.
Absorption
The general physico-chemical properties of the substance : molecular weight (212.0 g/mol), water solubility (
4.77 g/L)
and partition coefficient (log Kow =1.6) indicate that significant absorption by the oral route can be expected..Supporting results from the acute oral toxicity and Oral (Gavage) Repeated Dose Toxicity Study indicate absorption from the
gut.
Distribution
Information relating to the distribution of the substance is limited; however, the chemical
characteristics and findings from the Oral (Gavage) Repeated Dose Toxicity Study implies
systemic distribution would most likely occur via the serum following oral administration and gastric
absorption.
Metabolism
There is evidence of test item on metabolite influenced hepatic metabolism from the Oral (Gavage)
Repeated Dose Toxicity Study, with single cell necroses and slightly increased single-cell fatty degeneration in the liver,
Excretion
The most plausible route of clearance for low molecular weight, water soluble chemicals would be by renal excretion of substance or metabolites; there is evidence of substance mediated toxicity in the kidney, with congestion of the medullary-cortex border and protein casts in the nephrons.
Applicant's summary and conclusion
- Conclusions:
- The available information suggests that absorption of substance from the gastrointestinal tract following oral ingestion is highly likely based uponthe test items physico-chemical characteristics and relevent toxicity observed following oral dosing..
These characteristics together with the low volatility of the substance and particle size also indicate absorption via inhalation exposure of test item to be unlikely. Given the skin corrosivity of the substance and favorable physico-chemico properties, extensive dermal absorption can be expected. Any absorbed test material has the potential to undergo hepatic transformation and subsequent renal clearance.
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