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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Persistence Assessment

A fraction of 71% of the substance was degraded in a standard OECD biodegradation test (Guideline No. 301b)

after 28 days. Although the 10-day window validation criterion was failed, lanolin fatty acids, as a UVCB, can

be considered as readily biodegradable.

This is supported by calculations done with BIOWIN v4.10 which give no evidence for persistence (Biowin 2:

probability of rapid biodegradation=0.82; Biowin 3: ultimate biodegradation timeframe prediction=3.24 weeks).

Therefore, the substance is not considered as P in line with the screening criteria presented in the REACH

guidance chapter R.11.

Bioaccumulation Assessment

Based on the log KOW of 7.73, bioaccumulation can not be excluded. The EUSES model and the BCFBAF

model included in EPI SuiteTM v4.0 (US EPA, 2009) were used to predict the bioconcentration factor (BCF).

The predicted BCF differ considerably depending on the used model (EUSES: 32300 L/kgwwt, BCFBAF: 56.23

L/kgwwt).

However, as a risk management measure and basing on the current knowledge that lanolin fatty aids and

structurally-related substances are readily biodegradable, long-term exposure to organisms is unlikely to be

significant, such that the bioaccumulation of lanolin fatty acids in aquatic organisms is likely to be very

insignificant.

Therefore, based on the fact that lanolin fatty acids are readily biodegradable, the bioaccumulation property of

lanolin fatty acids may be considered to be of little safety concern.

Toxicity Assessment

In the available short-term studies on ecotoxicity no adverse effects were seen with saturated aqueous solutions.

It is unlikely that a chronic study will reveal adverse effects of the substance to aqueous organisms. The

substance is not classified as carcinogenic, mutagenic or toxic for reproduction.

Although no final assessment of the toxicity of the substance can be made in absence of a long-term study on

marine or freshwater organisms, it is considered unlikely that the substance fulfils the T-criterion.

Summary and overall Conclusions on PBT or vPvB Properties

The substance is not persistent in the environment and is therefore neither classified as PBT nor as vPvB.