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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 942-754-1 | 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:
- 0.027 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 27 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 2.7 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 2.7 µg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 14.27 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 1.43 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 2.84 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 53.33 mg/kg food
- Assessment factor:
- 300
Additional information
Reliable calculation method results are available to assess the aquatic toxicity of the registered substance, on aquatic invertebrates, algae and fish, for acute and chronic exposure.
The algorithm is based on a QSAR model which has been validated to be compliant with the OECD recommandations for QSAR modeling (OECD, 2004b, 2007). The ecotoxicological predictions were determined using iSafeRat® calculation method adapted for a mixture of compounds with the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e.non-polar narcosis). QSAR models are based on validated data for training sets for which the concentrations of the test substance had been determined by chemical analyses over the test period.
No toxic effects were observed up to the attainable limit of solubility of the substance in experimental acute studies for the three trophic levels (fish, aquatic invertebrates and algae). Maximal solubility of the test item in water, is the loading rate of 2.73 mg/L
According to these predictions and the experimental study:
- The acute 48-EL50 value for aquatic invertebrates, based on mobility, was predicted to be >solubility limit 2.73 mg/L ;
- The acute 72h-ErL50 and NOELr value for algae, based on growth rate, was predicted to be > solubility limit = 2.73 mg/L ;
- The acute 96h-LL50 value for fish, based on mortality, was predicted to be > solubility limit = 2.73 mg/L ;
-The chronic 21d-EL10 value for aquatic invertebrates, based on reproduction, was predicted to be 0.23 mg/L
- The chronic 32d-EL10 value for fish, based on growth or reproduction, was predicted to be 0.46 mg/L
In addition, an experimental acute Daphnia study (NOACK, 2015) is available. In this study, two non GLP range-finding tests were performed on the registered substance according to OECD Guideline 202 and EU Method C.2. The biological effects of the first and the second range-finding tests are consistent at 0.7 mg/L (5% immobilisation) and 1 mg/L (10% immobilisation). Therefore, the 48h-EC50 value is expected to be greater than 1 mg/L based on analytically confirmed nominal concentrations. As this value strongly supports the acute iSafeRat® prediction obtained on aquatic invertebrates, and the substance falls under the definition of "difficult to test" according to OECD guidance No. 23, the definitive study was not considered necessary.
One experimental long term toxicity study to aquatic invertebrates is avalaible. - The chronic 21d-EC10 value for aquatic invertebrates, based on reproduction, was determined to be 0.268 mg/L (95% CL: 0.194 - 0.371 mg/L).
Finally, an experimental study is available to assess the toxicity of the registered substance to microorganisms. In this study (Envigo, 2017), performed according to OECD Guideline 209, no statistically significant toxic effects were observed on the respiration of activated sludge microorganisms after a contact time of 3 hours at all of the test concentrations employed (10, 100 and 1000 mg/L). The 3h-EC50 value was determined to be greater than 1000 mg/L and the 3h-NOEC was 1000 mg/L.
Environmental fate and pathways
With only 32% biodegradation after 28 days of incubation (OECD Guideline 301D), the registered substance is considered as not readily biodegradable.However, in the prolonged Close Bottle test, the substance was biodegraded by 62% at day 60. This indicated that the registered substance undergoes a biodegradation and should be considered as non-persistent following the EU PBT/vPvB criteria. Regarding hydrolysis potential, the study is technically not feasible based on the poor water solubility of the substance.
The average bioconcentration factor (BCF) of the registered substance determined, by read-across, at 373 L/kg indicate that the substance did not bioaccumulate in the rainbow trout (in vivo OECD Guideline 305 and in vitro biotransformation assay). Finally, the adsorption coefficient (log Koc) of the registered substance determined, by read-across also, at 3.72 (OECD Guideline 121), indicate that the substance is immobile in soil (according to Mc Call et al., 1980).
Conclusion on classification
No harmonised classification is available.
Data available:
- not readily biodegradable;
- average BCF value of 373 L/kg on a read-across substance (in vivo OECD Guideline 305 and in vitro biotransformation assay using liver S9 fractions and hepatocytes from rainbow trout)
- acute data: no acute toxic effects were observed on all trophics levels at or even close to the water solubility of the substance.
- chronic data: Chronic effets were observed at 0.268 mg/L for daphnid.
Classification according to the Annex I of the Regulation (EC) No 1272/2008 (CLP): The test substance is classified as Aquatic Chronic 2 for the environment, based on acute toxicity data and the non ready biodegradability.
* Ahlers J, Riedhammer C, Vogliano M, Kühne R-U and Schüürmann G (2006) Acute to Chronic Ratios in Aquatic Toxicity – Variation across Throphic Levels and Relationship with Chemical Structure. Environmental Toxicology and Chemistry 25:2937-45.
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.