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:

Persistence

Results from the tests conducted on BPA 1-4.5EO suggest that the substance should be considered as inherently biodegradable. Work with the BPA 1-4.5EO shows biodegradation of up to 34% after 28 days.

 

Bioaccumulation

A study was conducted to assess the aquatic bioaccumulation of the test substance. The study is considered reliable as it was conducted on the registered substance according to OECD Testing Guideline 305. The BCF of the test substance was found to be < 41.7 at a concentration of 3.84 μg/L, and < 4.2 at a concentration of 38.5 μg/L. Such BCF is significantly lower than the screening threshold indicated in Annex XIII of the REACH Regulation.

Two studies were conducted to assess the octanol-water partition coefficient of the test substance.

Both studies were considered reliable as they were conducted on the registered substance according to OECD Testing Guideline 117, using the HPLC method. The key study gave a Log Kow 2-3.2 at 23°C and pH 6.3. The supporting study gave a Log Kow 2.77-3.94 at 30°C, with 78% of the test material having a Log Kow between 3.00 and 3.2. Substances are generally considered to be bioaccumulative when the log Kow ≥ 4.5, therefore, based on the results of these studies the test substance is unlikely to be bioaccumulative.

 

Toxicity

In accordance with Annexes VII and VIII of REACH, no long-term toxicity study on the registered substance were performed for the purpose of this registration and no data on the long-term toxicity for marine/freshwater organisms was identified. The Chemical Safety Assessment conducted according to Annex I of REACH did not indicate a need to investigate further the effects to the aquatic environment. Therefore no long-term toxicity testing on aquatic species was performed in accordance with Annex IX, Column 2, of REACH. When no long-term toxicity data is available on aquatic species, screening values reported in Table R.11-6 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (ECHA, 2017) can be used. The lowest short-term L(E)C50 available on the registered substance is 64 mg/L reported on Oncorhynchus mykiss. This value is higher than the screening threshold for T properties of 0.1 mg/L.

The substance is not classified as carcinogenic, mutagenic, or toxic for reproduction based on available data on the substance.

The substance demonstrated no evidence of chronic toxicity during endpoint testing.

 

Conclusion

The substance is not considered to be PBT or vPvB.