Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Persistence assessment:

Screening criteria:

A hydrolyse study shows that the substanceis not considerable to be abiotic degradable.The substance is inherent biodegradable under the conditions applied in a Zahn-Wellens test, reached the pass level (60 % biodegradation) in the 10-day window, and showed a maximum value of degradation of 98 % during the test period of 13 days.

Conclusion of Persistence assessment:

The substance is not considered to be persistent in the environment.


Bioaccumulation assessment:

Screening criteria:

The substance has a very low log Kow of -3.79 at 22 °C, which is far below 4.5. Therefore the substance is not considered to be bioaccumulative. The available data support the final conclusion that the substance is not expected to distribute both in soil and air. The low log Koc, as well as the extremely low Kair-water value is indicating that negligible distribution in these two compartments can be expected.

Conclusion of bioaccumulation assessment:

The substance is not considered to be bioaccumulative.


Toxicity assessment

Criteria based on Annex XIII of REACH:

- Not T based on the following criteria:

·   EC50 / LC50 >= 0.1 mg/L for marine / freshwater organisms (short-term toxicity):

The short-term aquatic toxicity values for freshwater test organisms are close or > 100 mg/L.

Only the acute aquatic toxicity value for freshwater daphnia with 48h-LC50 = 63.6 mg/L leads to a classification for the environment.

·   Substance is not classified as carcinogenic (cat 1 or 2), mutagenic (cat 1 or 2), or toxic for reproduction (cat 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (cat 1A or 1B), germ cell mutagenic (cat 1A or 1B), or toxic for reproduction (cat 1A, 1B or 2) according to Regulation EC No 1272/2008.

·   No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC) or specific target organ toxicity after repeated exposure (STOT RE cat 1 or 2) according to Regulation EC No 1272/2008.

 Conclusion of Toxicity assessment:

The substance is not considered to be toxic to the aquatic environment.

The substance shows no mutagenic toxicity with and without metabolic activation in vitro.

The substance shows no high toxicity after repeated exposure (NOAEL = 50 mg/kg bw/kg).

Likely routes of exposure:

No emission characterization is required since the substance is not a PBT or vPvB substance.