Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
0.002 mg/kg soil dw

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Adequate chronic toxicity data are not available for Acid Brown 355 (ABr355), therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available.

The key values chosen for Chemical Safety Assessment concerning the aquatic compartment are the following:

- for the short-term toxicity to fish (Brachydanio rerio and Leuciscus idus) the effect level was recorded in the range of 10 and 100 mg/l

- for short-term toxicity to aquatic invertebrates (Daphnia magna) the EC50 (48h) resulted to be greater than 100 mg/l

- for toxicity to aquatic plants other than algae (Lemna minor) the EC50 (7d) based on growth rate and yield were estimated to be 22.7 and 227 mg/l, respectively

- for toxicity to microorganisms no respiration inhibition was recorded up to the highest concentration tested of 100 mg/l

The outcomes of the tests performed on the three trophic levels showed that the substance can affect both fish and aquatic plants.

The short-term effect level on fish was recorded between 10 and 40 mg/l (in one study EC50 (96h): 40 mg/l; in the other one EC50 (96h) was stated in the range 10 - 22 mg/l) and the EC50 related to the effects on the grown rate in the Lemna study confirms the effects magnitude (ErC50 (7d): 22.7 mg/l). In order to derive the PNEC water (both freshwater and marine water), the short-term effect level of the most sensitive species was chosen. Thus, the lowest value of the effect concentrations range has been selected.

Conclusion on classification

Adequate chronic toxicity data are not available; Acid Brown 355 (ABr355) is not readily biodegradable and has a negative log kow (-0.0752).

On the basis of the short-term toxicity data on the three trophic levels (details above), ABr355 can be classified as hazard to the aquatic environment in category 3 (H412), according to the CLP Regulation (EC 1272/2008).