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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No hazards were identified for the compartments freshwater and sediment, marine water and sediment, air, and soil, since there were no adverse effects whatsoever on the test organisms in aquatic toxicity tests up to the limit test concentration. Therefore, negative impact of the substance Reactive Red F00-0124 on organisms living in the aforementioned compartments need not be expected. Due to absence of any significant bioaccumulation potential, organisms in the food chain (predators) are not at risk of secondary poisoning. For microorganisms in the STP, respiration inhibition was observed in an activated sludge test at excessively high test concentrations (1,000-10,000 mg/L). At the guideline compliant limit test concentration of 1000 mg/L, 7.3 % respiration inhibition were measured, and at 10,000 mg/L microbial respiration was inhibited by 49 %. The highest test concentration may thus be selected in lieu of a "true" EC50, providing a basis for PNEC derivation. Accordingly, a PNEC of 100 mg/L can be derived for the STP. However, an exposure assessment and risk characterisation for the STP is not necessary, for the following reasons:

  • Reactive Red F00-0124 is neither classified for any of the hazard classes referred to Article 14(4) of the REACH Regulation, nor is it a PBT/vPvB substance
  • The concentration response curve for respiration inhibition of activated sludge is only gently inclined (increase from 7.3 % to less than 50 % effect over test concentrations spanning an order of magnitude); accordingly, the effect is mild

Considering the low severity of the effect on microorganisms, and the generally benign toxicity profile of the substance, the PNEC of 100 mg/L is adequately protective against any impairment of STP performance; a quantitative risk characterisation is not considered to be necessary.

Conclusion on classification

According to the results of guideline-compliant aquatic toxicity tests on the test item there is no evidence of adverse effects to fish, invertebrates or algae up to the limit test concentration of 100 mg/L. The substance is well soluble in water and has a very low partition coefficient (< -4.5) hence there is no significant potential for bioaccumulation. Accordingly, the criteria for classification for environmental hazards as specified by Regulation (EC) No 1272/2008 are not fulfilled. The test item does not to be classified as hazardous to the environment.