Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

Persistence

 

The test item has been determined to meet the criteria for ready biodegradation (OECD 301 B) and, in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014) does not fulfil the criteria for ‘persistence’.

 

Bioaccumulation

 

The substance a complex UVCB for which uptake of components is considered to be unlikely due to low water solubility (1x 10E-05 g/L at 20 ± 0.5 °C) and Log Kow values that were determined to lie between 5.75 to > 10. Further evidence of limited uptake leading to bioconcentration is provided by molecular weight of components (> 100 g/moL where dermal absorption is less favourable) and the absence of acute dermal toxicity (LD50 > 2000 mg/kg bw). On the basis of these data it is considered that the actual Log10 Kow for this substance is > 10 where, in accordance with ECHA guidance Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014), the aquatic BCF of a substance is expected to be lower than the threshold value of 2000 L/kg for bioaccumulation.

 

Toxicity

 

Based on available evidence, and in accordance with Regulation EC No 12/72/2008, the substance does not meet the criteria for classification as carcinogen (category 1A or 1B) or germ cell mutagen (category 1A, 1B or 2). Furthermore there is no evidence of chronic toxicity and the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2).Results from short-term environmental tests on three trophic levels provide no evidence of toxicity and current regulatory obligations do not require long-term testing. However, the available acute data are considered screening information andcannot be used to definitively conclude not T even though the substance is not classified as environmentally hazardous (seeECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014)).

Likely routes of exposure:

Human exposure via the dermal route plus release to the environment via waste water.