Registration Dossier
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EC number: 229-851-8 | CAS number: 6786-83-0 with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Marine water
- Hazard assessment conclusion:
- no data available: testing technically not feasible
STP
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Sediment (freshwater)
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Sediment (marine water)
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Assessment of PBT/vPvB Properties
The relevant PBT (persistent, bio accumulative, toxic) criteria according to the REACH regulation and the corresponding properties of the chemical are as compiled in the table mentioned below:
Criterion | Annex XIII - PBT criteria | Annex XIII - vPvB criteria | Result - Solvent blue 4 | Inference |
P | Half-life in marine water = > 60 d, or or | Half-life in marine, fresh or estuarine water = > 60 d, or or | The chemical is considered to be non- biodegradable as the half-life of water is 180 d.
| Yes |
B | BCF > 2000 | BCF > 5000 | Bio accumulative since BCF value is 10000 | Yes |
T | Long-term NOEC for marine or freshwater organisms < 0.01 mg/l | - | As per Column 2 (Annex VII and VIII) of the REACH regulation, a study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes. | No |
T | CMR | - | No | |
T | Other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC | - | No |
The table demonstrates that the substance does fulfil the P and B criteria but does not fulfil the T criteria.
A substance is identified as a PBT substance if it fulfils all three PBT criteria described above. These criteria are not fulfilled, and therefore the substance cannot be classified as PBT.
So, Solvent blue 4 is neither a PBT nor a vPvB substance
Conclusion on classification
Classification is not triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
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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