Registration Dossier

Diss Factsheets

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Hydrolysis

This study is not required because based on available analogue read across, the substance is considered to be readily biodegradable.

Biodegradation

In a key OECD Guideline 301B ready biodegradability study (ABC Laboratories Ltd., 2016b), the mean percent theoretical CO2 produced by test substance (Santicizer P1700) was 31.1% by Day 29 of the study. Since the biodegradation value was less than 60%, Santicizer P1700 cannot be classified as readily biodegradable, but may be inherently biodegradable. A further OECD 310 ready biodegradation study (Scymaris 2020a) was found to be invalid due to uncertainty around the validity criteria and the high variation in biodegradation between replicates.

Data is also available for the structural analogue,Santicizer S278 (Reaction Mass of Benzyl (1R,1S) 2,2,4-trimethyl-1-[(2-methylpropanoyl)oxy]pentan-3-yl benzene-1,2-dicarboxylate and Benzyl (3R,3S) 2,2,4-trimethyl-3-[(2-methylpropanoyl)oxy]pentyl benzene-1,2-dicarboxylate) and is used based on analogue read across. A discussion and report on the read across strategy is provided as an attachment in Section 13 of the dossier.

The ready biodegradability of the Santicizer 278 was determined in a 28-day biodegradation study performed in accordance with OECD 301B. The test material was considered to be readily biodegradable under the strict terms and conditions of the test.

Bioaccumulation

This data is being read across from the source study that tested Santicizer S278 (benzyl 3-(isobutyryloxy)-1-isopropyl-2,2-dimethylpropyl phthalate) based on analogue read across. A discussion and report on the read across strategy is provided as an attachment in Section 13 of the dossier.

The Bioconcentration Factor (BCF) of Santicizer 278 was calculated using the "modified Connell" parabolic equation provided in the R.7c Information Requirements guidelines and using the estimated log Kow of 7.0. A Bioconcentration Factor (BCF) of 45709 L/Kg (log BCF of 4.66) was calculated using this equation.

Adsorption / Desorption

This data is being read across from the source study that tested Santicizer S278 (benzyl 3-(isobutyryloxy)-1-isopropyl-2,2-dimethylpropyl phthalate) based on analogue read across. A discussion and report on the read across strategy is provided as an attachment in Section 13 of the dossier.

The mean estimated log Koc for Santicizer 278 is 5.383.

Additional information