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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:

8. PBT AND VPVB ASSESSMENT

8.1. Assessment of PBT/vPvB Properties

8.1.1. Summary and overall conclusions on PBT or vPvB properties

The results reported in Chapter 4.1 Degradation indicate that the substance is neither

persistent (not P) nor very persistent (not vP) in the environment.

Furthermore the results reported in Chapter 4.3 Bioaccumulation demonstrate that the

substance has a low potential to be bioaccumulative (not B) and is not very bioaccumulative

(not vB). Based on the results obtained from the aquatic toxicity studies documented in

Chapter 7.1 (Aquatic compartment including sediment) and the data on mammalian toxicity

studies (Chapter 5. Human Health Hazard Assessment), the substance is considered not toxic

(not T).

8.1.2. PBT/vPvB criteria and justification

Data for the definitive conclusion on the PBT or vPvB properties of the substance are not

available. Thus, the screening criteria given in the ‘Guidance on information requirements and

chemical safety assessment, chapter R.11: PBT assessment’ (ECHA, 2008) are used as

surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB

criteria.

Persistence Assessment

The screening criterion for persistence is the potential of a substance for ready

biodegradation. As the substance Isopropyl myristate is readily biodegradable, the substance

is considered to be not persistent and does not meet the “P” criterion.

Bioaccumulation Assessment

The screening criterion for bioaccumulative substances, which has to be classified as “B” or

“vB”, is a log Kow > 4.5. The log Kow value (calculated) of the test substance is 7.71

(Chapter 1.3). As a result, the substance Isopropyl myristate is predicted to bioaccumulate on

the basis of its physico-chemical properties. However, as the substance is readily

biodegradable, no chronic exposure of aquatic organisms is expected. Should the substance be

taken up by fish, the group of linear aliphatic fatty acid esters has been shown to be rapidly

metabolised and excreted via the enzyme carboxylesterase. A QSAR calculation reveals a

bioaccumulation potential with 2765 L/kg as regression based estimate, however a low

bioaccumulation potential with the more realistic Arnot-Gobas method including

biotransformation with a resulting BCF value of 122.1 L/kg (upper trophic). Therefore, in

accordance with the ECHA Guidance Document R.11, the substance has presumably a low

potential to be bioaccumulative (BCF < 2000 L/kg) and is not very bioaccumulative (BCF <

5000 L/kg).

Toxicity Assessment

The screening criterion for toxicity is based on short-term aquatic toxicity studies. Aquatic

organisms (algae, daphnia, and fish) did not show any toxicity up to the limit of the water

solubility (< 0.05 mg/L). Hence, the substance will not be classified as “T” substance.

In addition, the substance is not classified as carcinogenic, mutagenic or toxic for

reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC

and Regulation (EC) No 1272/2008. Therefore, the substance does not meet the “T” criterion.