Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-824-8 | CAS number: 68334-33-8
- 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:
- 6.2 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.002 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.62 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.21 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 55 mg/kg sediment dw
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 11 mg/kg sediment dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 7.3 mg/kg soil dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
No aquatic toxicity studies with the test substance are available. Therefore, studies with DHTDMAC (CAS 61789-80-8), DMDTC (CAS 68783-78-8) and DODMAC (CAS 107-64-2) were used as read across to fulfil the data gap for the test substance. The primary component of all substances provide complete coverage of 68334-33-8. 68334-33-8 shares high structural similarity with 61789-80-8, 68783-78-8, 107-64-2, and 112-02-7. As 68334-33-8 is a UVCB its components encapsulate the other substances except for the counter ion (Cl-). In solution, the counter ions will dissociate from the parent structures. Therefore, we are comparing substances of equivalent nature. CAS 107-64-2 represents the C18 boundary of the 61789-80-8. Ignoring the salt component CAS 61789-80-8 is equivalent to CAS 68334-33-8. 68783-78-8 is a worst case of both 68334-33-8 and 61789-80-8 since it is unsaturated and the SP2 carbon-carbon bonds are of higher reactivity and a more likely site of metabolic activation. The primary component of CAS 112-02-7 is a substructure of all the other substances. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.
A European Risk Assessment Report has been issued in 2002 by German Authorities for read-across substances. Some of the previously defined PNECs were revisited according to this core document but all the PNECs remain very similar to those presented in the EU RAR.
Conclusion on classification
Based on read-across to analogous substances, the test substance is considered as very toxic for the aquatic compartment based on the generated aquatic toxicity package with a 48-hour EC50 in daphnia of 0.16 mg/L and a 5-day NOEC in algae of 0.062 mg/L, and the fact that it is not readily biodegradable, the test substance is classified as Cat 1 (H400: Very toxic to aquatic life) for acute aquatic toxicity and as Cat 1 (H410: Very toxic to aquatic life with long lasting effects for chronic aquatic toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
In accordance with article 10 of the CLP Regulation (EC) No 1272/2008, if an M-factor is not yet given in Part 3 of Annex VI to the CLP Regulation, an M-factor should be determined and a scientific justification provided, when classifying substances for Acute Category 1 or Chronic Category 1. For this substance, adequate acute aquatic data are available in fish, aquatic invertebrates, and algae. An Acute M-Factor is based on the lowest reported effects in the most sensitive species fish, aquatic invertebrate and algae. Therefore, the M factor is 1 based on the 96-hr EC/LC50 of 0.62 mg/L in fish, the 48-hr EC/LC50 of 0.16 mg/L in aquatic invertebrate and the 96 h EC/LC50 of 0.36 mg/L in algae.
The current data support an M-factor of 1. However, the substance was tested in river water which contains suspended solids to which very adsorptive substances like cationic amines will bind. Therefore, exposure to nominal concentration of cationic amine is reduced (adsorbed material is not bioavailable). A conservative 90% of the nominal concentration was considered to adsorb on suspended solids. Only exposure to 10% of the nominal concentration was considered and therefore an additional safety factor was applied, resulting in a chronic M-factor of 10.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.