Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

The registration of the test material employs a combined approach for addressing the required endpoints. When data are not available, data from the read across substances are used to address the required endpoints.

The read across substances are structurally similar to registered substance. The substance and the proposed structural analogues are predominantly C32 – C36 alkyl fatty amides. These substances are expected to be metabolised by fatty acid amide hydrolase and esterases. Any differences among the substance structures are not expected to result in any significant differences in the toxicological effects or degradation products.

The following endpoints are addressed using data from read across:

  • Bioaccumulation

 

Stability

Hydrolysis

According to 9.2.2.1. Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the hydrolysis of a substance does not need to be conducted if the substance water solubility is below 0.1mg/L at 20°C. The test material has a water solubility of less than 0.0506 mg/L, therefore, this endpoint is waived.

Biodegradation

Biodegradation in water: screening test

In a study conducted according to OECD 301B, under GLP conditions, the test material attained 26% degradation after 28 days and, therefore, is not readily biodegradable

Biodegradation in water and sediment

In an OECD 308 study, conducted according to GLP, the test material dissipated rapidly from the water of both aquatic sediment systems, with DT50 values of 2.6 days (Calwich Abbey Lake) and 10.4 days (Emperor Lake).  The DT50 value in the sediment phase of Calwich Abbey Lake was 811 days, based on two sampling intervals.  The DT50 value for the decline in the sediment phase of Emperor Lake could not be calculated, as the test material (as % applied parent) continued to increase until the last sampling interval.  Decline in the overall aquatic sediment system was slow and corresponded to DT50 values of 657 days (Calwich Abbey Lake) and 636 days (Emperor Lake).

Due to the low solubility of the test material and rapid partitioning from the aqueous phase to the sediment, aerobic mineralisation in surface water – simulation biodegradation testing according to OECD Testing Guideline No. 309 is considered technically not feasible.  

Biodegradation in soil

In an OECD 307 study, conducted according to GLP, the mean distribution and recovery of radioactivity ranged from 99.7 to 106.2% AR in Cuckney soil, 93.9 to 103.4% AR in Drayton soil, 97.6 to 107.2% AR in Elmton soil, and 95.2 to 106.2% AR in Calke soil.  Low levels of radioactivity were detected in the bound residues (mean values ≤10.6% applied radioactivity) and mean mineralization of the test item to CO2 was less than or equal to 0.9% applied radioactivity.  There was little or no evidence for degradation of test material in soil at 12 +/- 2 deg C and pF2, under aerobic conditions, and kinetic analysis of the data was therefore considered inappropriate.

 

Bioaccumulation

Bioaccumulation

To address the bioaccumulation endpoint a QSAR assessment, using the Estimation Programs Interface (EPI) SuiteTM BCFBAF v3.01, was completed as part of a weight of evidence approach on the primary constituent of the test material and 2 appropriate read across substances oleyl palmitate (CAS RN number 16260-09-6) and stearyl erucamide (CAS RN number 10094-45-8).

 

  • Primary constituent: The BCF was predicted to be 381.4 L/kg ww by BCFBAF v3.01 (EPISUITE, 2013).
  • Oleyl palmitate : The BCF of oleyl palmitate was predicted to be 113.1 L/kg ww by BCFBAF v3.01 (EPISUITE, 2013).
  • Stearyl erucamide: The BCF of stearyl erucamide was predicted to be 113.1 L/kg ww by BCFBAF v3.01 (EPISUITE, 2013).

Based on the above information, as a worst case example, the primary constituent presented the highest BCF value of 381.4 L/kg ww. This value has therefore been used to represent the bioaccumulation potential of the test material

Based upon the estimated BCF of 381.4 L/kg ww, the test material is not expected to bioaccumulate in the environment.

 

Transport and Distribution

Adsorption/desorption

The adsorption coefficient (Koc) of the test material is greater than 4.27 x 105, resulting in a log10 Koc > 5.63, based on the reference standard with the highest log10 Koc  tested.  This value indicates that the test material is immobile in soil.