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PBT assessment

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PBT assessment: overall result

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

8.1. Assessment of PBT/vPvB Properties - Comparison with the Criteria of Annex XIII

The criteria set out under REACH for determining whether a substance is PBT/vPvB are as follows:

Criterion

PBT criteria

vPvB criteria

P

Half-life (T½) > 60 d in marine water or

Half-life (T½) > 40 d in fresh or estuarine water or

Half-life (T½) > 180 d in marine sediment or Half-life (T½) > 120 d in fresh or estuarine water; sediment or

Half-life (T½) in soil > 120 d

Half-life (T½) > 60 d in marine fresh or estuarine water or

Half-life (T½) > 180 d in marine, fresh or estuarine water; sediment

Half-life (T½) > 180 d in soil

B

BCF > 2000 L/kg in fresh or marine aquatic species

BCF > 5000 L/kg

T

Chronic NOEC < 0.01 mg/l for marine or freshwater organisms, or

Substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) or

There is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Not applicable

Note: (a) BCF is bioconcentration factor, NOEC is no-observed effect concentration and CMR is a substance classified as carcinogenic, mutagenic or toxic for reproduction

(b) For marine environmental risk assessment, half-life data in freshwater sediment can be overruled by data obtained under marine conditions

(c) Substances are classified when they fulfil the criteria for all three inherent properties for P, B and T. However, there is certain flexibility, for instance in cases where one criterion is marginally not fulfilled but the others are exceeded considerably.

 

These criteria are the definitive criteria for PBT assessment. However, the first step in the PBT assessment is to conduct a screening assessment using screening criteria. Once this screening step is conducted evaluation against the definitive criteria listed above can be conducted using measured data is appropriate. If a substance is confirmed to be PBT/vPvB a third step is required to estimate the amounts of substance released to the different environmental compartments from all activities and uses will need to be reported in section 8.2 of this report.

8.1.1. Persistence Assessment

Based on the available measured data, cyclopentane is not biodegradable. Therefore, based on initial persistence screening the substance could be considered to meet Persistent (P) or very Persistent (vP) criteria. However based on the analysis by CONCAWE (CONCAWE 2010) this substance is not considered to meet the criteria for persistant.

8.1.2. Bioaccumulation Assessment

As a screening criteria, it has been established that if the log Kow of the substance is lower than 4.5 it indicates that the substance will not fulfill the bioaccumulative (B) or very bioaccumulative (vB) criteria.The calculated BCF of 70.8 indicates that cyclopentane does not greatly bioaccumulate in the lipids of ecological receptors. The log Kow of 3 was used to calculate the BC. Therefore cyclopentane is not expected to fulfill the bioaccumulative (B) or very bioaccumulative (vB) criteria.

8.1.3. Toxicity Assessment

The substance cyclopentane is not identified as PB or vPvB, therefore a toxicity assessment is not needed