Registration Dossier
Registration Dossier
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EC number: 412-780-3 | CAS number: 1380226-46-9 ADDITIV 104
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.004 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.036 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 0.004 mg/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:
- 5.63 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.563 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:
- 1.25 mg/kg soil dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential to cause toxic effects if accumulated (in higher organisms) via the food chain
Additional information
Conclusion on classification
Additiv 104 can be considered insoluble in water, and in addition a substance made of multiple components of very high molecular weights and thus likely not bioavailable to create toxic effects. The hazard classification (R-51/53 or GHS 4 -11) comes from the most sensitive of 3 acute tests on freshwater organisms (Daphnia 48 -hr EC50/NOEC = 6.8/3.6 mg/L, respectively; when fish and algae showed that the acute endpoints were in excess of 10 mg/L). The aquatic tests were conducted as water accommodated fractions or WAFs, and owing to the complexity of the substance and inherent properties the analytical verifications have been based on indirect measurements.
Releases to the environment under normal conditions are minimal, and hence releases due to spills should be limited and easily contained for proper disposal. Al
hough the estimated concentrations have only limited relevance to the actual concentrations, a screening assessment indicates that the substance is less hazardous than what is assigned by GHS, and until better proof can be generated the conservative classification can be considered sufficient.
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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