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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:

 

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 Alcohols, C20-30 (even numbered) does not meet the PBT or vPvB criteria. No further testing is required. Conclusions for each crtieria are as follows:

 

Persistence: Biodegradation studies for constituents of Alcohols, C20-30 (even numbered) and analogue long chain alcohols demonstrate that Alcohols, C22 -30 (even numbered), branched and linear is readily biodegradable and therefore not persistent (P) or very persistent (vP) under aerobic conditions.

 

Bioaccumulation: Alcohols, C20-30 (even numbered) 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 Alcohols, C20-30 (even numbered) is not bioaccumulative (B) or very bioaccumulative (vB).

 

Toxicity: Based on available reliable data for toxicityto substances that are themselves constituents of as well as analogous to the primary components of alcohols, C24 -28, 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.

 

Alcohols, C20-30 (even numbered), 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 Alcohols, C20-30 (even numbered).