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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Behenyl Bottoms can be characterised as Alcohols, C18‐22, distillation residues and does not fulfil the screening criteria for persistence, bioaccumulation, and toxicity. The overall conclusion is that Behenyl Bottoms does not meet the PBT or vPvB criteria.

Persistence (P) Assessment:

Results of the ready biodegradability tests with Behenyl Bottoms demonstrate that it is inherently biodegradable in fresh water (Schaefer & Matthews, 2010). The test substance biodegraded to an extent of 84.1% after 60 days and can be regarded as inherently biodegradable. According to ECHA Guidance, when the half-life is greater than 40 days in freshwater, the substance is considered to be persistent. Based on an average of three replicates and the steady rate of biodegradation, it can be assumed that the half-life of the substance is below the persistence (P) criterion when 50.3% of the substance biodegraded in a freshwater environment by day 37 of the test (Schaefer & Matthews, 2010). In accordance with ECHA Guidance (Chapter R.11, PBT Assessment), Behenyl Bottoms does not fulfil the PBT or vPvB criteria for Persistence (P) and is considered to be unavailable for uptake by sediment organisms.

Bioaccumulation (B) Assessment:

Behenyl Bottoms cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms, Behenyl Bottoms does not fulfill the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According to ECHA Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11‐2: Integrated testing strategy for B assessment, no further testing is required to conclude on the bioaccumulation criterion. The data requirement for bioaccumulation studies in aquatic and terrestrial organisms is waived on the evidence of technical difficulties and the absence of toxicity in aquatic organisms and mammals. A bioconcentration factor (BCF) for Alcohols, C18-22, distillation residues was calculated using EPISuite (BCFBAF v. 3) based on a range of SMILES notations for the constituent substances and the extrapolated log Kow of >7.17 (Schutt and Nixon, 2010). The resulting BCF was 2,780 (log BCF was >3.44). However, predicted BCFs for long chain alcohols have been shown to be overestimates (OECD SIDS, 2006; Veith et al., 1979 and Connell and Hawker, 1988).

Toxicity (T) Assessment:

Based on available reliable data for toxicity Behenyl Bottoms short‐term acute toxicity (LC50 or EC50) to aquatic organisms is >0.01 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). Chronic data on aquatic species showed No effect concentrations NOECs >0.01 mg/l and therefore the criteria of Annex XIII REACH for aquatic toxicity are not fulfilled.

Also, the substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.

In addition, no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008, is available for the substance.

Therefore, it can be concluded that the substance does not fulfill the Toxicity criteria as laid down in Annex XIII of regulation (EC) No 1907/2006.