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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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:
- (Q)SAR
- Remarks:
- Danish QSAR data base is used for LD50 of constituents and total acute toxicity is calculated according to additivity formula from CLP regulation and based on actual analytical information of the constituents in the intermediate substance.
- 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:
- Applied DTU QSAR models are documented in QMRFs and include more than 600,000 substances. Constituents' identification are from actual analytical information performed using 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 identification are from actual analytical information GC-MS (and headspace) reports as well as adding C>4 hydrocarbons representative identifier from EPI Suite to provide a comprehensive assessment that covers complete range of known and probable hydrocarbons within the intermediate substance. All information are docuemnted and attached in the dossier.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database are used for calculation of total toxicity according to formula introduced for mixtures in CLP regulation, both normal and conservative estimation applied.
- Version / remarks:
- Rat Oral LD50 data of constituents/ingredients from ACD labs provided by Danish QSAR database are used for calculation of total toxicity according to formula introduced for mixtures in CLP regulation, both normal and conservative estimation applied.
- 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 C>4 hydrocarbons representative identifier from EPI Suite to broaden the carbon range of hydrocarbons and provide a comprehensive assessment that covers complete range of known and probable hydrocarbons. All information are docuemnted and attached in the dossier. The ATE of the intermediate substance according to additivity formula is: 100/ SUM (Ci / ATEi) where Ci is concentration of each constituent and ATEi is lethal dose ( Oral Rat LD50) of the constituents from Danish QSAR database. In addition, conservative formula is also applied that is 100- (SUM Ci unknowns) / SUM (Ci/ATEi). Conservative formula according to CLP regulation assumes that the rest of constituents in the UVCB substance are also similar to identified constituents that have less than 2000 mg/kg/d LD50.
- GLP compliance:
- not specified
- Remarks:
- Calculation based on constituents lethal dose data from Danish QSAR database that uses ACD labs experimental information as input to CLP regulation formula for mixtures both (normal and conservative estimation)
- 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 Both normal and conservative estimation.
Test material
- Reference substance name:
- Hydrocarbons from mixed waste plastics, thermo-mechanical depolymerization condensate
- Molecular formula:
- C5-C29
- IUPAC Name:
- Hydrocarbons from mixed waste plastics, thermo-mechanical depolymerization condensate
- Test material form:
- liquid
- Details on test material:
- Hydrocarbons from mixed waste plastics, thermo-mechanical depolymerization condensate. It is a complex combination of hydrocarbons as described in section one.
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. 7 131.2 mg/kg bw
- Based on:
- other: Oral rat LD50 data of constituents from ACD labs provided by Danish QSAR database as input to acute toxicity estimation formula provided by CLP regulation.
- 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:
- Conservative formula assuming only 44,4% applicable constituents data result in 3169,1 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 performed in standard laboratories and combined with C>4 hydrocarbon representative data from EPI suite for more coverage 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 because in normal estimation the effect dose result is 7131,2 and in conservative estimation result is 3169,1 mg/kg/bw in which both results are above 2000 mg/kg/bw.
- Executive summary:
The intermediate substance is a combination of recovered hydrocarbons from waste plastics 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 the substance according to additivity 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 calculation is also performed that assumes only 44,4% of the identified constituents data from GC/MS are applicable. Therefore, the formula changes to 44,4/ SUM (Ci / ATEi) according to CLP regulation which is very conservative. However, both scenarios of normal and conservative calculations results are more than 2000 mg/kg/bw (7131,2 and 3169,1 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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