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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The registered substance is readily biodegradable and therefore is not considered persistent (P) or very persistent (vP). In addition, with a log Kow lower than 4.5, the registered substance does not meet the criterion for bioaccumulation (B). For the T criterion, the acute E(L)C50 values are comprised between 6.15 and 8.1 mg/L for the three trophic levels. In addition, chronic effects can be determined. Three chronic data are available for the registered substance. Unfortunately none of the studies appear to have been conducted according to GLP and therefore the results cannot be considered valid under the REACH Regulation. Nevertheless the studies may be considered useful in a weight of evidence approach. The 72h-NOEC value for growth inhibition of the freshwater green algae was 2.5 mg/L. The 8-day NOEC from a test performed on C. dubia was determined to be 1.07 mg/L for both reproduction and for the survival of the adult test animals. The 9 day NOEC for hatching and the survival of fish larvae was 1.5 mg/L based on the geometric means of the exposure concentrations. Due to the high water solubility of the registered substance, the substance is expected to have reached equilibrium within the test period and therefore the 9 d study can be considered adequate to indicate chronic effects using this sub-lethal endpoint. Therefore, as these chronic values are well greater than 0.01 mg/L, the registered substance is not considered toxic.

In conclusion, the registered substance could not be considered as a PBT or vPvB substance.

Likely routes of exposure:

None