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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

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

The majority of the data set for this substance is read across to the free acid form; however it is clear that in any biological system (and hence for the safety evaluation of human or environmental hazard assessment) there will be no difference between the qualitative effects of Reactive Yellow 201 (as a mixture of free acid, single and disodium salts) and the free acid form. In the production of both the free acid form and Reactive Yellow 201, the method of synthesis is identical up to the point of final isolation. The pH of the solution at isolation will affect which salt is produced, the dry pure product will either possess the Na or the H group on the charged oxygen. As soon as the material is dissolved again, the equilibrium will be reached almost instantly and at an acid pH the ionised form will be predominant.

No hazards were identified for the compartments freshwater and sediment, marine water and sediment, air, and soil, since there were no adverse effects on the test organisms in aquatic toxicity tests that would trigger classification. Therefore, negative impact of the substance "Reactive Yellow 201" 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, at the guideline compliant limit test concentration of 1000 mg/L, no respiration inhibition was measured, which is therefore the NOEC. Overall, the substance is not hazardous to the environment; PNEC values cannot be derived.

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 (< –4.35) 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 need to be classified as hazardous to the environment.