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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.304 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
3.04 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
30.4 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.304 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:
1.63 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.163 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:
0.148 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The reactive orange 16 was administered to zebrafish in fresh water at concentration of 500 mg/L for 96 hours after the method described in OECD 203. No mortality and no symptoms were observed . The test substance was stable throughout the experimental period. (Markert M. Weigand W. 1985)

The Oryzias Latipes was tested with reactive black 5 (read across for reactive orange 16) for 14 days in fresh water. At dose 100 mg/L no effect was observed.

The Reactive Orange 16 shows acute toxicity to Daphnia Magna at very high doses. The concentration goes from 600 mg/L for LC100 and 304 mg/L for LC50 to 88.4 mg/L for no observed effect concentration. (Wellens 1986)

Reactive orange 16 shows a moderate toxicity to algae EC50 7.8 mg/L (Novotný 2005) and also in marine compartement, but this has been demostrated as the risult of shading effect, the real toxicity is suppose to be greater than 100 mg/L. Test substance shows no toxicity on microorganims.

On soil and sediment no tests are conducted because the exposure is unlikely

Conclusion on classification

Based on Regulation 1272 -2008 table 4.1.0 the lowest LC50 value is up to 100 mg/L. Based on this results it can assess that Reactive Orange 16 is not classified for environment toxicity.