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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

P criteria

The substance is not readily biodegradable according to both the ready biodegradability tests. Degradation of the the substance: 0% in 28 days (no degradation observed).

The substance is then considered to be persistent in the environment were exposure to occur based on the known lack of biodegradability.

B criteria

The measured bioconcentration factor (BCF) was found to be ca 80, wich means the material is not considered to have potential for bioaccumulation

 

T criteria

Eco-toxicity studies:

The toxicological examination on fish, daphnia and algae provided a LC50(96h) >1000 mg/L(Danio Rerio), an EC50(48h)> 500mg/L (Daphnia Magna) and an EC50 (72h)> 80 mg/L (Desmodesmus subspicatus).

 

Mammalian toxicity studies:

Also in this case the toxicological examination for genetic toxicity demonstrated a lack of mutagenic response.

The substance was not mutagenic or genotoxic when tested in vitro in a bacterial reverse mutation assay, a cell gene mutation test and an in vitro mammalian chromosome aberration assay.

A pre-natal developmental toxicity was conducted and no developmental toxicity was observed (NOAEL =1000 mg/kg bw/day).

Considering all the available toxicological information the substance can be assessed as not toxic.

 

The substance may pose a persistence (P) hazard but as the results produced no bioaccumulation (B) or toxicity (T) properties the substance cannot be considered as a PBT/vPvBT.

Since the criteria for B and T are not fulfilled, the substance is not PBT or vPvB