Registration Dossier

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
half-life in fresh or estuarine water = > 40 d, or
half-life in marine sediment = > 180 d,

or
half-life in fresh- or estuarine water sediment = > 120 d, or
half-life in soil = > 120 d

Half-life in marine, fresh or estuarine water = > 60 d,

or
Half-life in marine, fresh or estuarine sediment = > 180 d,

or
half-life in soil = > 180 d

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.