Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

Reference
Name:
Phenol, mono-C24-28 (even)-sec-alkyl derivs, ortho- and para-
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Potentially P or vP

The test item attained only 48 % biodegradation after 28 days (OECD 301B and EU Method C.4-C) and is a complex mixture for which investigation of hydrolysis via OECD 111 and EU Method C.7 is not suitable because components that are unstable could have their own hydrolytic rate and some components may be stable leading to conflicting results. In accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017), the substance is considered to be potentially persistent or very persistent.

Not B or vB

The substance a complex UVCB for which uptake of components is considered to be unlikely due to low water solubility (1.0 x 10E-03 gTOC/L at 20.0 ± 0.5 °C from a loading rate of 0.1 g/L) and Log Kow > 10 where, in accordance with ECHA guidance Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017), the aquatic BCF of a substance is expected to be lower than the threshold value of 2000 for bioaccumulation. 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) in mammals.

Potentially T

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (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 tests on three trophic levels provide no evidence of environmental toxicity and current regulatory obligations do not require long-term testing. Nevertheless, the available acute data are considered screening information and cannot be used to definitively conclude not T even though the substance is not classified as environmentally hazardous (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment; Version 3.0, June 2017).

Likely routes of exposure:

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