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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
- 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:
- 0.003 mg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.001 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 1 mg/kg soil dw
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
See justification of PNECs.
As the algae study can be considered to provide a chronic endpoint, it was considered applicable to use the algal NOEC as a chronic endpoint (along with the Daphnia reproduction study), in assigning assessment factors for aquatic PNECs.
Conclusion on classification
The substance has been evaluated for environmental classification against the current CLP criteria (Regulation (EC) No 1272/2008)
It is considered that a classification of Chronic Category 2 is appropriate based on the available data.
Based on the results of acute testing in fish, daphnia and algae no acute aquatic classification is required, as no effects were observed at the limit of solubility (i.e. the highest obtainable test concentration) in these studies.
Based on the results of the acute toxicity testing, ready biodegradation and log Pow the 'safey net' classification of Chronic Category 4 is not required, as although the substance is poorly soluble and no effects were seen at the limit of solubility in the acute studies and the substance is not readily biodegradable, the log Pow of 2.51 is below the classification criteria for log Pow ( ≥ 4).
However, adequate chronic toxicity data is available from a 21 -day Daphnia reproduction study.
In this study Daphnia magna were exposed to an aqueous solution of the test material over a range of test concentrations of 0.0040, 0.013, 0.040, 0.13 and 0.40 mg/l for a period of 21 days. The test material solutions were prepared by producing a saturated solution with a nominal concentration of 0.40 mg/l. The remaining test concentrations were prepared by dilution of the saturated solution.
The "Lowest Observed Effect Concentration" was considered to be 0.40 mg/l on the basis that at this test concentration significantly fewer live young per adult were produced when compared to the control.
The "No Observed Effect Concentration" was considered to be 0.13 mg/l on the basis that at this test concentration there were no significant mortalities (immobilisation) observed in the parental generation (P1) and that there were no significant differences between the control and the 0.13 mg/l test group in terms of numbers of live young produced per adult by Day 21.
The NOEC of 0.13 mg/l is sufficient for classification based on the CLP criteria given in Table 4.1.0, b) i) of the CLP regulation, which states that:
Non-rapidly degradable substances for which there are adequate chronic toxicity data available, Chronic Category 2 is applicable when the chronic NOEC for crustecea is >0.1 to ≤1 mg/l.
Therefore, the NOEC of 0.13 mg/l obtained from the Daphnia reproduction study means the substance should be classified as Aquatic Chronic Category 2 (H411: Toxic to aquatic life with long lasting effects).
EC10 values from chronic studies can also be used for classification instead of the NOEC value. No EC10 value was stated in the Daphnia reproduction study, but have been calculated based on the study data.
The EC10 has been based on the number of juveniles per adult. This endpoint was used for the NOEC and is considered the most relevant effect.
The EC10 was calculated to be 0.29 mg/l.
As EC10 or NOEC should be used for chronic classification, based on the calculated EC10 of 0.29 mg/l, classification in Chronic Category 2 would still apply. As the EC10 is also below the water solubility of the substance, it should be considered as a relevant result for classification.
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