Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

This substance is a reaction mass of dipropylene glycol dibenzoate (DPGDB) and diethylene glycol dibenzoate (DEGDB). No testing has been performed on the reaction mass itself but data are available for DPGDB and DEGDB individually. All the studies were performed according to international test guidelines and in compliance with GLP. They are presented below, by component.


 


DEGDB:


Short-term toxicity to fish:


- Key study, reliability 1, OECD 203, rainbow trout - LC50 (96h) = 1.12 mg/L


- Supporting study, reliability 1, OECD 203, fathead minnow - LC50 (96h) = 1.85 mg/L


 


Short-term toxicity to aquatic invertebrates:


- Key study, reliability 1, OECD 202, Daphnia magna - EC50 = 3.05 mg/L


 


Toxicity to aquatic algae and cyanobacteria:


-Key study, reliability 1, OECD 201, Raphidocelis subcapitata.  The ErC10, ErC20, and ErC50 (growth rate 0-72 hours) were 1.6, 2.1, and 3.7 mg/L respectively.  The EyC10, EyC20, and EyC50 (yield 72 hours) were 0.48, 0.70, and 1.4 mg/L respectively.


- Disregarded study, reliability 3,OECD 201, Pseudokirchneriella subcapitata - The test substance was not anaytically detected at the end of the study and therefore it was determined that the geometric mean of the exposure concentrations was unreliable and the study should be repeated.


 


Toxicity to microorganisms:


- Key study, reliabiltiy 1, OECD 209, activated sludge of a predominantly domestic sewage - EC50 (3 h) > 100 mg/L and NOEC (3 h) >= 100 mg/L


- Supporting study, reliability 2, ISO 10712 Determination of the inhibitory effect of water constituents on bacteria Pseudomonas cell multiplication inhibition test, Pseudomonas putida - EC10 and EC50 > 10 mg/L, NOEC >= 10 mg/L


 


DPGDB:


Short-term toxicity to fish:


- Key study, reliability 1, OECD 203, fathead minnow - LC50 (96h) = 3.7 mg/L


- Supporting study, reliability 1, OECD 203, rainbow trout - LC50 (96h) > 3.0 mg/L


- Supporting study, reliability 2, QSAR calculation (EPIWIN-ECOSAR v1.00) - LC50 = 3.94 mg/L


- Disregarded study, reliability 3, OECD 203, fathead minnow - LL50 > 100 mg/L, NOELR = 0.8 mg/L, poor correlation of nominal levels with measured concentrations


- Disregarded study, reliability 3, OECD 203, rainbow trout - LL50 = 0.25 mg/L, NOELR = 0.06 mg/L, poor correlation of nominal levels with measured concentrations


 


Short-term toxicity to aquatic invertebrates:


- Key study, reliability 1, OECD 202, Daphnia magna - EC50 = 5.0 mg/L


 


Long-term toxicity to aquatic invertebrates


- Key Study, reliability 1, OECD 211, Daphnia magna: LOEC (reproduction & length) = 5.6 mg/L, NOEC (reproduction & length) = 2.2 mg/L, EC10 (reproduction) = 2.5 mg/L, EC10 (length) = >5.6 mg/L


 


Toxicity to aquatic algae and cyanobacteria:


- Key study, reliability 1, OECD 201, Pseudokirchneriella subcapitata - The EbC50 (biomass 72 h) was 0.70 mg/L and the ErC50 (Growth rate 0 - 72 h) was 3.2 mg/L. The EbC50 (biommass 96 h) was 0.62 mg/L and the EbC50 (Growth rate 0 - 96 h) was 2.5 mg/L.


The 72 and 96 hour "no-observed effect concentrations" (NOEC) for growth rate were 0.68 and 0.27 mg/L, respectively.


 


Toxicity to microorganisms:


- Key study, reliabiltiy 1, OECD 209, activated sludge of a predominantly domestic sewage - EC50 (3 h) > 100 mg/L and NOEC (3 h) >= 100 mg/L


- Supporting study, reliability 1, ISO 10712 Determination of the inhibitory effect of water constituents on bacteria Pseudomonas cell multiplication inhibition test, Pseudomonas putida - EC10 and EC50 > 10 mg/L, NOEC >= 10 mg/L


 


These data demonstrate that DPDGB and DEGDB have similar environmental profiles with all short-term EC50 values in the range of >1.0 mg/L and <10 mg/L. Long-term toxicity are underway and will be assessed upon completion. The most sensitive endpoint result currently available for these components has been used as the key value to evaluate hazard and is highlighted below.


 


The current key values used in the chemical safety assessment are:


Short-term aquatic toxicity EC/LC50 = 1.12 mg/L (DEGDB rainbow trout)


Long-term aquatic toxicity NOEC = 0.68 mg/L (DPGDB, 72 hour algal growth rate)


Toxicity to micro-organisms = 100 mg/L

Additional information