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EC number: 442-480-8 | CAS number: 182893-11-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Adequacy of study:
- supporting study
- Reliability:
- other:
- Rationale for reliability incl. deficiencies:
- other: No studies are available on the toxicokinetics, metabolism and distribution of Methyl isopropyl ketone peroxide. Predictions were made based on physical-chemical properties and stability data.
Data source
Materials and methods
- Principles of method if other than guideline:
- Predictions based on physical-chemical properties and stability.
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The toxicokinetic profile of the substance shows that based on physical-chemical characteristics and stability data, particularly water solubility, octanol-water partition coefficient and vapour pressure, no or only limited absorption by the dermal and inhalation routes is expected, which is further supported by the dermal and inhalation acute toxicity studies results. For the oral route uptake is more relevant. Bioaccumulation products is not likely to occur. Excretion is expected to occur mainly via urine.
- Executive summary:
There is no direct in vitro or in vivo experimental data on toxicokinetics for MIPKP. The discussion on toxicokinetics is therefore based on the available physico-chemical and stability data.The available physico-chemical and toxicological information of the substance has been evaluated and used to assess the toxicokinetic behaviour. The results of this analysis will address the question on how the chemical will react in the body. The ECHA “Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance June 2017” document provides guidance, which physico-chemical properties commonly determine oral, inhalatory and dermal absorption, distribution, metabolism and elimination of substances.
The substance MIPKP is a liquid at room temperature with a molecular weight of 136.1 / 238.3 (Monomer/Dimer) g/mol, respectively. The water solubility is high for the monomer and lower for the dimer. The log Pow of was calculated to be calculated 0.80 / 3.18(Monomer/Dimer) for MIPKP and also reflects this.
Absorption
Oral absorption is favoured for molecular weights below 500 g/mol. Based on the high water solubility and the low log Pow value MIPKP is expected to be readily absorbed via the GI tract. As the substances are water soluble and the molecular weight is low (less than 200/close to) MIPKP may pass through aqueous pores or be carried through the epithelial barrier by the bulk passage of water.
Administered in an acute study for MIPKP the oral LD50 is 200-2000 mg/kg bw. Mortality occurred at 2000 mg/kg bw. For MIPKP no advserse effects were observed up to 75 mg/kg bw/d in a 28-day and repro/developmental toxicity screening study. However, effects on the liver and bodyweight were observed. Therefore, it can be assumed that the substance becomes systemically available and direct absorption across the gastrointestinal tract epithelium will occur when applied orally.
Based on the low vapour pressure the inhalation exposure is limited. Nevertheless, if the substance reaches the lung, it may be absorbed. There is no inhalation data available for MIPKP.
Similarly, based on physical – chemical properties of MIPKP the substance is not likely to penetrate skin to a large extent as the low logPow value does not favour dermal penetration, as the substance is too hydrophilic to pass the skin. Furthermore, application to skin of rabbits did not cause systemic effects or mortality in acute dermal toxicity study at very high doses, 2000 mg/kg bw for MIPKP. In a skin irritation studies corrosion was observed but no mortalities. Applied to the skin of guinea pigs skin MIPKP is classified a weak sensitizer, reaction observed in 3/10 animals. Part of the reaction on the skin in these studies may be attributed to the corrosive/irritating nature of the substances.
Distribution
When reaching the body MIPKP will be widely distributed due to low molecular weight and high water solubility.
Metabolism
MIPKP is readily biodegradable and hydrolytically stable. The substance is probably sufficiently long-lived to become systemically available. Based on the structure of the molecules, metabolism in the human body will mainly consist of phase-II metabolising steps, leading to an even better water solubility for excretion. This is in compliance with the results obtained in the genotoxic tests showing no effects with and without metabolising system. Metabolic activation leading to more toxic metabolites is thus not very likely.
Excretion
The bioaccumulation factors (BCF) were calculated using the EPIWIN software. These values are calculated to be 58.25 L/kg or 1.765 log BCF for dimer and 3.262 L/kg or 0.5 log BCF for the monomer of MIPKP. Based on these properties the substances are not considered to bioaccumulate in the human body. For both substance based on the water solubility and the log Pow value, excretion via the urine is likely.
Summary
The toxicokinetic profile of the substance shows that based on physical-chemical characteristics and stability data, particularly water solubility, octanol-water partition coefficient and vapour pressure, no or only limited absorption by the dermal and inhalation routes is expected, which is further supported by the dermal and inhalation acute toxicity studies results. For the oral route uptake is more relevant. Bioaccumulation products is not likely to occur. Excretion is expected to occur mainly via urine.
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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