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Diss Factsheets
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EC number: 939-579-8 | 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
Link to relevant study record(s)
Description of key information
No studies are available. Based on molecular structure, molecular weight, water solubility and octanol-water partition coefficient, it can be expected taht both oral and dermal absorption rates are moderate, distribution in the body is wide and that elimination occurs mainly by metabolism. The nephrotoxicity observed in the 90-day toxicity study confirm that the substance has at least moderate oral absorption rate.
Key value for chemical safety assessment
Additional information
There is no reliable and relevant information source in which the toxicokinetic properties (absorption, distribution, metabolism, elimination) of the submission substance were investigated. The expected toxicokinetic behaviour is derived from the physicochemical properties and the results from the available toxicological data following the guide given in the REACH guidance document R.7c.
CHIMEXANE HB is a substance composed of constituents having a molecular weight in the 379-519 g/mol range. It is a pasty solid with an estimated water solubility above 158.4 mg/L at 20°C. Vapour pressure was determined to be 0.0085 Pa at 20°C and it has lipophilic properties (3<log Kow<4.5 for the main constituents, extrapolated log Kow= 4 for the submission substance). The surface tension is 30.08 mN/m at 20°C at 1000 mg/L. More details regarding these data can be found in the section 4 of CHIMEXANE HB IUCLID dossier.
Absorption:
In an acute oral toxicity study, the major clinical signs observed in animals dosed 2000 mg/kg bw were hypoactivity, piloerection and dyspnea. Lower body weight gain was observed in the surviving animal dosed 2000 mg/kg bw and in 1/5 females dosed 300 mg/kg bw. The systemic toxicity effects observed at 2000 mg/kg bw indicate that thesubmission substance is absorbed when administered orally at high doses.
In an acute dermal toxicity study, no systemic effects were observed at 2000 mg/kg bw CHIMEXANE HB. However, the submission substance has a molecular weight < 500 and is a lipophilic substance (log Kow = 4) and has moderate water solubility: dermal absorption is therefore expected. Also, as the substance has also corrosive properties, damage to the skin surface may enhance penetration.
In a 90-day repeated dose toxicity study, tubular necrosis with clinical chemistry changes were observed in animals dosed 450 mg/kg bw/day CHIMEXANE HB. These effects indicate that the submission substance is absorbed when administered orally at moderately high doses.
Thus, indications of oral and dermal uptake of CHIMEXANE HB/the submission are given. Therefore the bioavailability of CHIMEXANE HB/the submission substance can be considered to be existent but maybe limited.
Distribution:
Available physico-chemical data (low molecular weight, lipophilicity and moderate water solubility) indicate that the submission substance could be distributed to many tissues and, due to its lipophilicity, may have a particular affinity for fatty tissues.
Metabolism:
No data are available but differences in cytotoxicity were observed with and without the use of a metabolic activation system in differentin vitrogenotoxicity studies (HPRT,chromosome aberration assay). This indicates that the submission substance may be metabolised by hepatic microsomal fractions.
Excretion:
As nephrotoxicity was observed in the 90-day repeated dose toxicity study, it can be considered that the submission substance and its metabolites are excreted in urine.
Accumulative potential:
Based on some toxicological studies that provide indications on CHIMEXANE HB absorption and metabolism (repeated dose toxicity study and genotoxicity studies) and on physico-chemical information (molecular weights < 500 and log Kow =4), it is concluded that CHIMEXANE HB is partially bioavailable, it is also likely to be metabolized by hepatic enzymes and excreted. Therefore, the potential for bioaccumulation is expected to be low.
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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