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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
Justification:

The criteria of Annex XIII REACH for aquatic toxicity are not fulfilled. 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. The overall conclusion is that olefines polymer, oxidized, hydrolyzed, distillation residues does not meet the PBT or vPvB criteria. No further testing is required. Conclusions for each crtieria are as follows:

Persistence: From a comparison of the results obtained for constituents of olefines polymer, oxidized, hydrolyzed, distillation residues (namely, icosan-1-ol, docosan-1-ol and 2 -decyltetradecanol) with the criteria of REACH Annex XIII, it can be concluded that olefines polymer, oxidized, hydrolyzed, distillation residues is not persistent (P) under aerobic conditions.

Bioaccumulation: Olefines polymer, oxidized, hydrolyzed, distillation residues cannot be regarded as bioaccumulative in aquatic, sediment or terrestrial organisms. The data requirement for bioaccumulation in aquatic and terrestrial organisms is waived on the evidence of technical testing difficulties, ready biodegradability and the absence of toxicity in aquatic organisms and mammals. Therefore, based on the criteria of REACH Annex XIII, it can be concluded that olefines polymer, oxidized, hydrolyzed, distillation residues is not bioaccumulative (B) or very bioaccumulative (vB).

Toxicity: Based on available reliable data for toxicity constituents of olefines polymer, oxidized, hydrolyzed, distillation residues (namely, icosan-1-ol and docosan-1-ol) short-term acute toxicity (LC50or EC50) to aquatic organisms is >0.01 mg/L, there is no evidence of chronic toxicity considering human health and no classification as carcinogenic (category 1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category 1, 2 or 3), and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment. Long-term toxicity is considered to be greater than the limit of solubility (LoS) for alcohols > C15 in chain length.

 

Olefines polymer, oxidized, hydrolyzed, distillation residues is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2). There is no evidence of chronic toxicity, as identified by the classifications: STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/ vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/ vapours, inhalation of dust/mist/fume) according to the CLP Regulation.

Likely routes of exposure:

The likely route of exposure to humans is via the dermal route. It is not anticipated that there is potential for significant inhalation exposure due to the relatively high molecular weight of Nafol 22 +.