Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

Reference
Name:
Reaction product of D-Glucopyranoside, methyl; esterified with octadecanoic acid, methyl ester
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
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

 

Not P or vP

 

The registered substance has been determined to be readily biodegradable and will not persist in the aquatic environment.

 

Bioaccumulation

 

Not B or vB

The registered substance a complex UVCB for which uptake of components is considered to be unlikely due to low water solubility (< 2.07 x 10E-05 g/L at 20.0 ± 0.5 °C from a loading rate of 0.1 g/L) and determined Log Kow of 7.37 to > 10.0. Bioaccumulation is therefore unlikely because, in accordance with ECHA Guidance on information requirements and chemical safety assessment Chapter R11: PBT/vPvB assessment (Version 2.0; November 2014), a decreasing relationship between BCF and Log Kow is observed at high Log Kow (> 6) and the aquatic BCF of a substance is likely to be < 2000 if the Log10 Kow value is higher than 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) in mammals when an analogue substance was investigated.

Toxicity

 

Potentially T

Based on available evidence for a close analogue, and in accordance with Regulation (EC) No. 1272/2008, the registered 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 isno 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 dataare 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.