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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 442-600-9 | 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.11 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.001 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.011 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 54 µg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 5.4 µg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 64.26 µg/kg soil dw
- Extrapolation method:
- sensitivity distribution
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 8 mg/kg food
- Assessment factor:
- 300
Additional information
The test substance HiTEC7134 is highly toxic to aquatic organisms, and is not readily biodegradable. Low L(E)C50 values were reported for the three species tested: fish, daphnia and algae, the invertebrate Daphnia magna being the most sensitive species. The 48-hour EC50 for daphnia was reported as 0.11 mg/L, and this value was used for the determination of the PNECs aqua. See above for the detailed description.
The calculation of the PNECstpwas performed using the NOEC from an activated sludge respiration inhibition study (NOEC = 100 mg/L).
The equilibrium partitioning method (EPM) was applied for the calculation of PNECs for sediment (freshwater and marine water) and soil, using an extrapolation from the PNECaqua. Note that HiTEC7134 is a highly lipophilic substance, with a Log kow between 6.4 - 7.6, and the EPM may underestimate toxicity for compounds with a Log Kow above 6. The ECHA guidance advises to increase the PECsed/PNECsed ratio by a factor of 10, in order to take uptake via ingestion of sediment into account (ECHA guidance R.10 page 33). The same principle accounts for the soil compartment (page 40).
To derive the safe level for oral exposure, the NOAEL for rats was used since the dossier does not contain toxicity data with birds (requirement only for Annex X substances). In this study an NOAEL of 15 mg/kg body weight/day was reported, from a repeated-dose toxicity study using the oral route of exposure.
There is also a newer reproduction/development toxicity study (Reproduction/developmental toxicity screening test of HiTEC 7134 in rats by oral gavage, Notox B.V.; project no. 496483; 2012) in which extra blood work was collected so it was more like the combined sub-acute oral/repro study. Based on the newer study, the new NOAEL is 120 mg/kg body weight/day. This value of NOAEL was used to calculate the PNECoralas described earlier.
For further details of PNEC derivation see attached spread sheet with calculations.
Conclusion on classification
HiTEC 7134 was highly toxic to all three species tested. The lowest L(E)C 50 value of 0.11 mg/L resulted from an acute toxicity study with Daphnia magna. The substance is not readily biodegradable, only 27% biodegradation was achieved after 28 days of exposure. Based on this information, HiTEC7134 Performance additive shall be classified for acute aquatic hazard Cat. 1 "H400: Very toxic to aquatic life" and also category 1 for chronic toxicity "H410: Very toxic to aquatic life with long lasting effects" in accordance with the CLP Reg (EC) 1272/2008.
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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