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:

1. Persistence:

Based on the data available from studies conducted to evaluate the biodegradation potential, it is noted that the test substance FAT 40045 showed low biodegradation potential under the study conditions and hence concluded to be not readily biodegradable and stable in the environment. Hence the substance can be regarded as P and/or vP.

2. Bioaccumulation:

The octanol-water partition coefficient of Reactive Blue 72 is determined to be - 5.33 (log Kow). This value is much below the threshold value of log Kow ≤ 4.5. Hence, Reactive Blue 72 regarded to be neither bioaccumulative nor very bioaccumulative.

3. Toxicity:

No long-term studies for marine or freshwater organisms are available. Hence, according to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfil the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. For the substance under consideration, the following EC50/L50 values were obtained: LC50 of 96 h fish toxicity study was found to be >1000 mg/L. 48 h EC50 for aquatic invertebrates was found to be >100 mg/L. The 7 d EC50 for Lemna gibba was found to be >100 mg/L. Based on the test data for all the three species (LC50 and EC50>100 mg/L), FAT 40045 can be classified as not toxic to aquatic organisms. Further, it has not been classified as carcinogenic, toxic to reproduction, mutagenic or causing specific target organ toxicity.

Taking the above discussion, it can be concluded that Reactive Blue 72 does not fulfil the PBT/vPvB criteria and hence it should be considered to be not PBT/vPvB.