Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

Given the Log Pow value of 1.44 for EC 202-228-8, it is concluded that the substance is of low concern for bioaccumulation and is therefore considered as not B or vB. This approach to determination of B and vB properties follows the guidance outlined in ECHA guidance Chapter R.11: PBT assessment.

The NOEL for growth rate in the 72 hour algal study was 1mg/L. EC 202-228-8 is not classified as carcinogenic, mutagenic or toxic for reproduction in accordance with CLP. EC 202-228-8 is not classified as T,R48 or Xn R48, nor is it classified as STOT RE Cat 1 or 2. It does not fulfil any of the appropriate T criteria for classification as outlined in REACH Annex XIII; therefore the material is concluded to not be T.

IUCLID section 5.2.1 Biodegradation in water: screening test outlines that in a ready biodegradation study (OECD 301F)

EC 202-228-8 was not readily biodegradable, showing cumulative biodegradation of 11% after 28 days. This data does not fulfil the specific criteria for identification of a P or vP substance as outlined in REACH Annex XIII Section 1.1.1. However this data can be used for screening and assessment of P and vP properties as outlined in REACH Annex XIII Section 3.1.1. Given the limited biodegradation seen in the OECD 301F study it is concluded that the substance may be P. However, the limited biodegradation seen in the OECD 301F study is likely to be due in part to the fact that EC 202-228-8 is inhibitory to microorganisms at the concentration used in the study, as demonstrated in an OECD 209 ASRIT study were a NOEC of <10 mg/L was established.

The above assessment was conducted using REACH Annex XIII and appropriate ECHA guidance documents. It is concluded that EC 202-228-8 is not PBT or vP/vB.