Santicizer P1400

Endpoint summary

Description of key information

Hydrolysis

The testing was conducted according to a procedure which is compatible with Method C7 Abiotic Degradation, Hydrolysis as a Function of pH of Commission Regulation (EC) No 440/2008 of 30 May 2008, Method 111 of the OECD Guidelines for Testing of Chemicals, 13 April 2004 and OCSPP Method 835.2120. The results of the study found that the estimated rate constants and half-lives at 25°C for the test item were; pH 4: estimated rate constant: 5.19x10-8 s-1 at 25°C, Estimated half life at 25 °C: 155 days. pH 7: estimated rate constant: 1.08x10-7 s-1 at 25°C, Estimated half life at 25 °C: 74 days. pH 9: estimated rate constant: 5.22x10-8 s-1 at 25°C, Estimated half life at 25 °C: 154 days.  

Biodegradation

There are four biodegradation studies available for P1400 which show that although it cannot be considered readily biodegradable it is rapidly biodegradable and meets the criteria for inherent biodegradation.

The key study for P1400 is an OECD 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test) performed in 2019. During this study P1400 attained a mean level of biodegradation (based on % ThIC) of 82% after 60 days, and the results showed good replication.  Less than 60% degradation was achieved within the 10-day window, so P1400 cannot be classified as readily biodegradable. However, P1400 exhibited the potential for rapid degradation and can be classified as inherently biodegradable.

In a Manometric Respiratory Test performed in accordance with OECD 301F, P1400 attained a mean level of biodegradation (based on the BOD:COD ratio) of 40% after 28 days and the results showed good replication. The test substance was also studied for biodegradation using the CO₂method according to OECD Guideline 301B and U.S. EPA OPPTS 835.3100. The mean percent theoretical CO2 produced by the test substance was 31.6% by Day 29 of the study.

The inherent ultimate and primary biodegradability of the test substance was also studied in a modified MITI (II) test equivalent to an OECD 302C and according to multiple Chinese chemical testing guidelines. The biodegradation of the test substance was calculated on the basis of Biochemical Oxygen Demand (BOD) and supplemented with chemical analysis of residual test concentrations. The test bottles incubated in C.E.S. Respirometer Systems at 25°C ± 2°C in the dark for over 28 days. At the end of the test, the test substance residual concentrations of the abiotic control and test suspensions were determined. Following the experiment, the following calculations were performed: (1) Theoretical Oxygen Demand (ThOD), (2) Biochemical Oxygen Demand (BOD), (3) Percentage biodegradation, (4) Abiotic degradation and (5) Primary degradation.

 

Under the conditions of the test, the percentage of ultimate biodegradation of the test substance, calculated by biochemical oxygen demand (BOD), was 59.5%. The primary biodegradation was determined to be 97.7% and the abiotic degradation rate was 50%. The results therefore show that the test substance was inherently biodegradable.

Bioaccumulation

The bioaccumulation factor was calculated using the EPISuite software, MODEL v4.11. In absence of experimental data, QSARs are theoretical models that can be used to predict the physico-chemical, biological and environmental fate properties of compounds based on their chemical structure. The Bioaccumulation Estimates (BCFBAF v3.01) of the material 1,2-Cyclohexanedicarboxylic Acid, 1-butyl 2-(phenylmethyl) ester / 1200806-67-2 / 810-685-5 was calculated using the Log BCF from regression-based method. The results is 3.158 (BCF = 1439 L/kg wet-wt).

Adsorption/Desorption

The determination of the test material 1,2-Cyclohexanedicarboxylic Acid, 1-butyl 2(phenylmethyl) ester was carried out using the HPLC screening method, designed to be compatible with Method C19 Adsorption Coefficient of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 121 of the OECD Guidelines for Testing of Chemicals, 22 January 2001. The testing determined that the adsorption coefficient (Koc) of the test item was 1.63 x 10^4, log Koc 4.21.