Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

DEGDB:

Short-term toxicity to fish:

- Key study, reliability 1, OECD 203, rainbow trout - LL50 (96h) = 2.9 mg/L

- Supporting study, reliability 1, OECD 203, fathead minnow - LL50 (96h) = 3.9 mg/L, NOELR =1.5 mg/L

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EL50 = 6.7 mg/L, NOELR = 1.0 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Key study, reliability 1, OECD 201, Pseudokirchneriella subcapitata - The 72h EL50 (Area under the curve, biomass) was 5.2 mg/L and the 72h EL50 (Growth rate) was 11 mg/L. The corresponding "No-observed effect loading rate" (NOELR) were 2.2 mg/L and 1.0 mg/L, respectively. The 96h EL50 (Area under the curve, biomass) was 5.9 mg/L and the 96h EL50 (Growth rate) was 15 mg/L. The corresponding NOELR for both were 2.2 mg/L.

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 - LL50 (96h) = 3.7 mg/L, LOEC = 1.2 mg/L

- Supporting study, reliability 1, OECD 203, rainbow trout - LL50 (96h) > 3.0 mg/L, NOELR = 3.0 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 levesl with measured concentrations

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

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EL50 = 19.3 mg/L, NOELR = 2.2 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Key study, reliability 1, OECD 201, Pseudokirchneriella subcapitata - The EL50 (Area under the curve 72 h) was 1.1 mg/L and the EL50 (Growth rate 0 - 72 h) was 4.9 mg/L. The corresponding "no-observed effect loading rates" (NOELR) were 0.22 and 1.0 mg/L, respectively. The EL50 (Area under the curve 96 h) was 0.95 mg/L and the EL50 (Growth rate 0 - 96 h) was 3.6 mg/L. A NOELR could not be obtained for Area under the curve 96 h, the NOELR for growth rate was 0.46 mg/L.

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

TEGDB

Short-term toxicity to fish:

- Key study, reliability 1, OECD 203, rainbow trout - LL50 (96h) = 16 mg/L, NOELR = 3.2 mg/L

- Key study, reliability 1, OECD 203, fathead minnow - LL50 (96h) > 100 mg/L, NOELR = 10 mg/L

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EL50 (48h) = 26 mg/L, NOELR = 4.6 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Key study, reliability 1, OECD 201, Pseudokirchneriella subcapitata - The EL50 (Area under the curve 72h and 96h) for TEGDB was 33 mg/L and the EL50 (Growth rate 0 - 72h and 0 - 96h) was >100 mg/L. The "No-observed effect loading rate" (NOELR) was 10 mg/L.

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

- Key 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

Additional information

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

The acute toxicity studies were carried out on freshwater fish species (rainbow trout and fathead minnow) and Daphnia magna. The algal growth inhibition studies were performed on Selenastrum capricornutum (Pseudokirchnerella subcapitata). The substance was introduced using a water accommodated fraction (WAF) and also in the case of DPGDB with fish, by flow through. In general the WAF studies suffered from low concentrations being measured in the initial WAF solution and subsequent losses of the test substance.

 

For each component an ASRIT study was performed to determine the effect on sewage micro-organisms. A second study on each component was also conducted to assess the effect on the growth of the bacteria Pseudomonas putida.These latter studies followed the method described in the German Water Hazard Classification Scheme, Bewertung Wassergefahrdender Stoffe LTWS Nr 10 and ISO 10712.

These data demonstrate that DPDGB and DEGDB have similar environmental profiles with all EC/EL/LC/LL50 values in the range of >1.0 mg/L and <20 mg/L. TEGDB is less toxic with EC/EL/LL50 values in excess of 16 mg/L.

The most sensitive endpoint result obtained for these components has been used as the key value to evaluate hazard and is highlighted below. Where no data exist an overall statement that applies to the reaction mass has been made. No further testing is proposed.

The key values used in the chemical safety assessment are:

Aquatic toxicity LL50 = 2.9 mg/L

Toxicity to micro-organisms = 100 mg/L

 

These values are from DEGDB, acute toxicity to rainbow trout and from the activated sludge respiration inhibition tests (ASRIT) performed on any of the components.

 

DEGDB

Short-term toxicity to fish

The results observed for the two species were similar and are presented below.

The 96 h LL50 value with rainbow trout was 2.9 mg/L. The NOELR was 0.06 mg/L (HLS 2001, VCL243/974218).

The 96 h LL50 value with fathead minnow was 3.9 mg/L. The NOELR was 1.5 mg/L (HLS 2001, VCL244/974219).

Short-term toxicity to aquatic invertebrates

The 48 hour EL50, immobilisation value with Daphnia Magna was determined to be 6.7 mg/L. The NOELR was 1.0 mg/L (HLS 2001, VCL264/974222).

Toxicity to aquatic algae and cyanobacteria

The EL50 (Area under the curve 72h) was 5.2 mg/L and the EL50 (Growth rate 0 – 72 h) was 11 mg/L while the EL50 (Area under the curve 96 h) was 5.9 mg/L and the EL50 (Growth rate 0 - 96 h) was 15 mg/L. (HLS 2001, VCL265/974223).

 Toxicity to microorganisms

In the ASRIT (HLS 1998, VCL245/970386) DEGDB had no significant inhibitory effect on the respiration rate of activated sludge at any of the concentrations employed in the tests. The NOEC was>=100 mg/L, the highest tested level.

 In the study on the bacteria Pseudomonas putida (Safepharm 1998, 1104/002), which supports the results from the ASRIT, EC10 and EC50 values of greater than 10 mg/L were obtained. The NOEC was >= 10 mg/L.

 

DPGDB

Short-term toxicity to fish

The results from the WAF tests with the two species showed no toxicity with one species and high toxicity with the other which was unexplainable. Because of the various problems with these two WAF tests, they are believed to be unreliable and have been disregarded. The flow through studies were well conducted exhibiting constant exposure levels throughout the studies and the results from both species were similar and in line with QSAR estimations.The results from the flow through studies are presented below.

The 96 h LC50 value with rainbow trout was >3.0 mg/L. The "no-observed effect concentration" (NOEC) was 3.0 mg/L (HLS 2000, VCL333/002268).

The 96 h LC50 value with fathead minnow was 3.7 mg/L. The NOEC was 1.2 mg/L (HLS 2000, VCL332/994962).

These values are supported by the QSAR modelling (EPIsuite ECOSAR v1.00, 2009) with a 96-hour LC50 value of 3.94 mg/L.

Short-term toxicity to aquatic invertebrates

The 48 hour EL50, immobilisation value with Daphnia Magna was determined to be 19.3 mg/L. The "no-observed effect loading rate" (NOELR) was 2.2 mg/L (HLS 2001, VCL252/974221).

Toxicity to aquatic algae and cyanobacteria

The EL50 (Area under the curve 72 h) was 1.1 mg/L and the EL50 (Growth rate 0 - 72 h) was 4.9 mg/L while the EL50 (Area under the curve 96 h) was 0.95 mg/L and the EL50 (Growth rate 0 - 96 h) was 3.6 mg/L. (HLS 2001, VCL 253/974220).

Toxicity to microorganisms

In the ASRIT (HLS 1998, VCL235/970385) DPGDB had no significant inhibitory effect on the respiration rate of activated sludge at any of the concentrations employed in the tests. The NOEC was >= 100 mg/L, the highest tested level.

In the study on the bacteria Pseudomonas putida (Safepharm 1998, 1104/001), which supports the results from the ASRIT, EC10 and EC50 values of greater than 10 mg/L were obtained. The NOEC was >= 10 mg/L.

TEGDB

Short-term toxicity to fish

The results observed for the two species indicate the substance is less toxic than either DPGDB or DEGDB.

The 96 h LL50 value with rainbow trout was 16 mg/L. The NOELR was 3.2 mg/L (HLS 2001, VCL282/974225).

The 96 h LL50 value with fathead minnow was >100 mg/L. The NOELR was 10 mg/L (HLS 2001, VCL283/974226).

Short-term toxicity to aquatic invertebrates

The 48 hour EL50, immobilisation value withDaphnia Magnawas determined to be 26 mg/L. The NOELR was 4.6 mg/L (HLS 2001, VCL281/974224).

Toxicity to aquatic algae and cyanobacteria

The EL50 (Area under the curve 72h and 96h) was 33 mg/L and the EL50 (Growth rate 0 – 72 h and 0 – 96 h) was >100 mg/L (HLS 2001, VCL284/974409).

Toxicity to microorganisms

In the ASRIT (HLS 1998, VCL286/973419) TEGDB had no significant inhibitory effect on the respiration rate of activated sludge at any of the concentrations employed in the tests. The NOEC was >= 100 mg/L, the highest tested level.

In the study on the bacteria Pseudomonas putida (Safepharm 1998, 1104/003), which supports the results from the ASRIT, EC10 and EC50 values of greater than 10 mg/L were obtained. The NOEC was >= 10 mg/L.

 

OTHER ENDPOINTS

Long term toxicity to fish

This study is proposed to be waived, based on the short-term testing results for the three components of the reaction mass and the rapid biodegradability of three substances.

Long term toxicity to aquatic invertebrates

This study is proposed to be waived, based on the short-term testing results for the three components of the reaction mass and the rapid biodegradability of three substances.

Toxicity to aquatic plants other than algae

No data available. No data required.

Toxicity to other microorganisms

No data available. No data required.