Registration Dossier
Registration Dossier
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EC number: 412-720-6 | CAS number: 156653-67-7
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 100 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.086 mg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.043 mg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.011 mg/kg soil dw
- Extrapolation method:
- sensitivity distribution
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 111.11 mg/kg food
- Assessment factor:
- 90
Additional information
The acute toxicity studies in Fish and Daphnia produced no adverse results, with respective EC50 / LC50 values presented as limits at > 220 mg/l and > 1000 mg/L (the limit of the test concentrations measured). The substance is not considered to be environmentally dangerous on this basis.
The original algae study conducted yielded the following results:
72 h EC50 growth rate > 70 mg/L (test substance only); >106 mg/l (test substance and impurities)
72 h EC50 biomass > 70 mg/L (test substance only); >106 mg/l (test substance and impurities)
72 h NOEC 18.2 mg/L
72 h LOEC 37.8 mg/L
Based on the effects noted, it was assumed that the results may be due to algistatic effects of the dyestuff, rather than actual toxicity observed. No classification and labelling is applicable. This was agreed by the German Member State Authority in the original notification of the substance under the 7th Amendment by another Dystar legal entity.
The substance is therefore proposed to be “not classified”.
Conclusion on classification
The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
Given the revised results for the Algae study, the results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute environmental effects is therefore required.
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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