Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.046 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.46 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.005 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
111.523 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
5 506.105 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
550.611 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:
2 638.861 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification of hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym C.I. Food Blue 3) for effects in the environment

In determining the classification appropriate to C.I. Food Blue 3, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below. 

 

Persistence

EPI Suite has estimated that hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 120 days (2880 hrs), does not exceeds the threshold of 120 days as per Annex XIII of REACH.Therefore, hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (C.I. Food Blue 3) is estimated to be not persistent in the soil environment. Estimations also indicate that the chemical is not likely to be persisitent in the water and sediment environment.

 

Potential to accumulate

The estimated bioconcentration factor (BCF) for hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is 3.162 L/kg, that does not exceed the bioconcentration threshold of 2000. Thus it is concluded that hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

 

Thus, the chemical does not satisfy the criterion for classification as bio-accumulative (B).

 

Toxicity

As per the criteria of Annex XIII of the REACH regulation, the chemical is not expected to qualify the criteria as Toxic. Thus, C.I. Food Blue 3 is a not toxic chemical.

 

In conclusion, it can be concluded that the chemical C.I. Food Blue 3 is not a PBT chemical.

Conclusion on classification

Aquatic 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.