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Diss Factsheets
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EC number: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: Calculation accoridng to CLP regulation for Acute Toxicity Estimate of mixtures based on information from Danish QSAR database and actual analytical information of the intermediate substance
- Remarks:
- Danish QSAR data base is used for calculation according to CLP regulation and based on actual analytical information of the constituents in the intermediate susbtance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Remarks:
- All applied DTU QSAR models are documented in QMRFs and include more than 600,000 substances. Constituents data are from actual analytical information attached and perofmed in standard laboratory procedures.
- Justification for type of information:
- Acute Toxicity estimate of mixtures is calculated according to the Tiered approach with additivity formula in CLP regulation. Oral lethal dose of constituents are extracted from valid Danish QSAR database that uses LD50 in rats data from ACD labs. Constituents data are from actual analytical information GC-MS (and headspace) data as well as adding C>4 hydrocarbons represntative data from EPI Suite to broaden the carbon range of hydrocarbons and provide a comprehensive assesment that cover complete range of known and probable hydrocarbons. All information are docuemnted and attached in the dossier.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database used for calculation according to CLP regulation, additivity formula
- Deviations:
- not applicable
- Remarks:
- Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database used for calculation according to CLP regulation, additivity formula
- Principles of method if other than guideline:
- Acute Toxicity Estimate (ATE) of substance (mixture of constituents) is calculated according to the Tiered approach with additivity formula in CLP regulation. Oral lethal dose of constituents are extracted from valid Danish QSAR database that uses LD50 in rats data from ACD labs. Constituents data are from actual analytical information GC-MS (and headspace) data as well as adding C>4 hydrocarbons represntative data from EPI Suite to broaden the carbon range of hydrocarbons and provide a comprehensive assesment that cover complete range of known and probable hydrocarbons. All information are docuemnted and attached in the dossier. The ATE of substance according to additivtiy formula is: 100/ SUM (Ci / ATEi) where Ci is concentration of each constituent and ATEi is lethal dose ( Oral Rat LD50) of the constituent from Danish QSAR database.
- GLP compliance:
- not specified
- Remarks:
- Calculation based on consituents lethal dose data from Danish QSAR databse that uses ACD labs experimental information
- Test type:
- other: Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database used for calculation according to CLP regulation, additivity formula
Test material
- Reference substance name:
- Hydrocarbons from waste rubbers and tires, thermo-mechanical depolymerisation condensate
- Molecular formula:
- unknown. explained in remark.
- IUPAC Name:
- Hydrocarbons from waste rubbers and tires, thermo-mechanical depolymerisation condensate
- Test material form:
- liquid
- Details on test material:
- Hydrocarbons from waste rubbers and tires, thermo-mechanical depolymerisation condensate
Constituent 1
- Specific details on test material used for the study:
- Analytical information of the substance constituents are utilized according to analytical information provided in the attachements.
Test animals
- Species:
- rat
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 9 886.7 mg/kg bw
- Based on:
- not specified
- Remarks:
- Data of constituents from Danish QSAR database that uses Oral rat LD50 from ACD labs
- Remarks on result:
- other: Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database used for calculation according to CLP regulation, additivity formula
- Remarks:
- Reported result is based on 100% constituent knwn data and Conservative LD50 result assuming only 40% applicable constituents data is also 3954,7 mg/kg/bw
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute Toxicity Estimate of the intermediate substance according to CLP tiered approach with additivity formula based on actual analytical information of the substance perofmed in standard laboratories and combined with C>4 hydrocarbon representative data from EPI suite for more covergae have resulted in more than 2000 mg/kg/bw in both scenarios of normal and conservative calculation. therefore, The intermediate substance that is combination of recovered hydrocarbons is not Acute toxic according to GHS criteria.
- Executive summary:
The intermediate substance is a combination of recovered hydrocarbons from waste rubbers and tires in which the analytical information is available and provided. Acute Toxicity Estimate (ATE) of substance (mixture of constituents) is calculated according to the Tiered approach with additivity formula in CLP regulation. Oral lethal dose of constituents are extracted from valid Danish QSAR database that uses LD50 in rats data from ACD labs. Constituents list are from actual analytical information GC-MS (and headspace) data as well as adding C>4 hydrocarbons represntative data from EPI Suite to broaden the carbon range of hydrocarbons and provide a comprehensive assesment that cover complete range of known and probable hydrocarbons. All information are docuemnted and attached in the dossier. The ATE of substance according to additivtiy formula is: 100/ SUM (Ci / ATEi) where Ci is concentration of each constituent and ATEi is lethal dose ( Oral Rat LD50) of the constituent from Danish QSAR database. Although the C>4 representative toxicity data has been added to broaden the estimation, a conservative secondary calcualtion is also perfomed that assumes only 40% of the detailed consituents data from GC/MS is applicable. Therefore, the formula changes to 40/ SUM (Ci / ATEi) according to CLP regulation which is more conservative. However, both scenarios of normal and conservative calculations result in more than 2000 mg/kg/bw ( 9886 and 3954 respectively) that implies the GHS criteria for acute toxicity can not be met.
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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