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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:

Although screening-level data do not indicate that the substance meets the strict criteria for ready biodegradability (failing the 10-d window in a ready biodegradability test), the substance has been shown to be rapidly biodegradable under conditions of a ready biodegradability test

(93% degradation in 27 d in one replicate of a ready biodegradability test, but failing the 10-d window) and under conditions of an

enhanced biodegradability assay (a replicate flask in the ready biodegradability assay for which the test was extended to 42 d).  In the absence of additional information to make a definitive determination for purposes of a PBT assessment, it may be presumed that the substance is potentially “persistent” (potentially “P”) and potentially “very persistent” (potentially “vP”), although the substance is not likely to be either.

 

Screening-level and definitive data indicate that the substance is “not bioaccumulative” (“not B”) and “not very bioaccumulative” (“not vB”). The screening-level determinations are based on an experimentally-determined log Kowof 3.63, which is below the screening criterion (log Kow4.5) for both “not B” and “not vB”.  

 

Definitive data indicate that the substance is “not toxic” (“not T”) with respect to mammalian and human health endpoints. The substance has not been determined to be “CMR”, “T, R48” or “Xn, R48” under the DSD/DPD classification. The substance has not been determined to be carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B or 2) or exhibit chronic toxicity (STOT-RE, category 1 or 2) under the CLP Regulation. The short-term screening-level data for aquatic toxicity (i.e., LC50in fish = 624 mg/L, EC50in invertebrates > 100 mg/L; ErC50 for algal growth inhibition > 100 mg/L) indicate that the substance is “presumably not T” with respect to aquatic toxicity (i.e., all L(E)C50values > 0.1 mg/L); however, this is not a definitive determination as long-term aquatic toxicity testing data are not available. Therefore, the substance has been determined to be not toxic (“not T”) by several screening and definitive criteria.

 

Therefore, although a complete definitive determination cannot be made with respect to all endpoints, the available screening level and definitive data indicate that the substance is potentially “P”, potentially “vP”, “not B”, “not vB”, and “not T”. It is not necessary to have definitive criteria for all five endpoints to make the determinations as to whether the substance is “not PBT” and “not vPvB”. The determination based on screening criteria only requires that “each of the three properties persistency, bioaccumulation and toxicity need to be considered in conjunction” (Chapter R.11, “PBT Assessment”,Guidance on information requirements and chemical safety assessment, ECHA, May 2008, Section R.11.1.2.2, p. 13.

 

In summary, the substance is “not PBT” (potentially “P”, “not B”, “not T”) and is “not vPvB” (potentially “vP”, “not vB”).