Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

 Stability

In accordance with Annex X of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, information regarding phototransformation in air, as well as in water and soil, is not mandatory information requirement.

 

Annex VIII Column 2 of the REACH Regulation states that a study on the Hydrolysis as function of pH does not need to be conducted if the substance is readily biodegradable. Therefore, a study on the Hydrolysis as function of pH is not required as Alcohols, C20-30 (even numbered), is readily biodegradable.

 

 

Biodegradation

In water:

Substances that are themselves constituents of and analogous to other primary constituents of Alcohols, C20-30 (even numbered), (eicosan-1-ol (C20), docosan-1-ol (C22), 2-decyltetradecanol (C24) and tetradecyloctadecan-1-ol (C32)) were assessed for ready biodegradability in reliable (Klimisch 1 or 2) OECD Guideline 301B studies (Ready Biodegradability: CO2 Evolution Test).

 

The key study by Flach (2014) reported 90% biodegradation of tetradecyloctadecan-1-ol in an OECD 301B CO2-evolution test over 28 days. More than 60% of tetradecyloctadecan-1-ol had degraded within the 10-day study window. Similarly, three studies examined the biodegradability of Isofol 24, 28, and 32 in an OECD 301F Electrolytic(Manometric) Respirometry Method test. Isofol 24 and 32 demonstrated ready biodegradability by reaching >60% ThOD within a 10 day window. However, Isofol 28 is considered inherently biodegradable achieving >60% ThOD in a 28 day period. The key study demonstrates that tetradecyloctadecan-1-ol, a C32 long chain alcohol, is readily biodegradable.

 

In other studies, 2-decyltetradecanol (C24) degraded by 84%, docosan-1-ol (C22) by 87.9% and 87.5% and eicosan-1-ol (C20) by 88.4% in 28-day tests confirming the ready biodegradability of these long chain alcohols (Flach (2012b), Federle (2009), Flach (2012a) and Federle (2009), respectively).

 

All of the experimental studies and evidence from the published literature demonstrate that constituents and analogues of Alcohols, C20-30 (even numbered) will degrade in the aquatic environment. It is concluded that given the very close similarity between LCA Category alcohols, 2-decyltetradecanol and tetradecyloctadecan-1-ol, as well as similar physico-chemical properties and structure, it is fully expected that Alcohols, C20-30 (even numbered) will rapidly and readily biodegrade in the environment.

 

In water and sediment:

In accordance with Annex IX Column 2 of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, the water and sediment simulation testing (required in Section 9.2.1) does not need to be conducted as the substance is readily biodegradable.

 

In soil:

In accordance with Annex IX Column 2 of the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, the water and sediment simulation testing (required in Section 9.2.1) does not need to be conducted as the substance is readily biodegradable.

 

In accordance with the Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, ‘mode of degradation in actual use’ is not a standard information requirement.

 

Bioaccumulation

The REACH requirement in Annex IX for a study on bioaccumulation in aquatic species is not needed if the substance has a low potential for bioaccumulation and/or a low potential to cross biological membranes. Accordingly the bioaccumulation data requirement is waived for Alcohols, C20-30 (even numbered). The waiver argumentations are based on the technical difficulties associated with conducting bioaccumulation studies, the ready biodegradability of the test substance, the low toxicity in aquatic organisms and the low toxicity in mammals resulting in the unlikely potential for secondary poisoning.

 

Transport and Distribution

In accordance with Annex VIII Column 2 of Regulation (EC) No 1907/2006 REACH concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, the adsorption/desorption screening test (required in Section 9.3.1) does not need to be conducted as the substance and its relevant degradation products decompose rapidly.