Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

Studies were conducted to determine the acute toxicity of the test material DEGDB to freshwater fish (Rainbow Trout and Fathead minnow). The studies were conducted according to EC, OECD, and US EPA test guidelines, and in compliance with GLP.

The 96 h LL50 value for DEGDB with rainbow trout was 2.9 mg/L, with the "no-observed effect loading rate" (NOELR) of 0.06 mg/L (HLS 2001, VCL243/974218).

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

For chemical safety assessment, the lowest value is chosen and therefore the LL50 of DEGDB for freshwater fish is 2.9 mg/L. The 96h LL50 to freshwater fish is shown to be <10 mg/L.

 

Long term toxicity to fish

This study is proposed to be waived, based on the short-term testing results and the rapid biodegradability of the substance.

 

Short-term toxicity to aquatic invertebrates

One study is available and valid.

An acute Daphnia Immobilisation study was performed to determine the acute toxicity to Daphnia of the test material DEGDB (HLS 2001, VCL264/974222). The study was conducted according to EC, OECD, and US EPA test guidelines, and in compliance with GLP. The 48 hour EL50 (immobilisation value for DEGDB with Daphnia Magna) was determined to be 6.7 mg/L. The NOELR was 1.0 mg/L.

 

Long-term toxicity to aquatic invertebrates

This study is proposed to be waived, based on the short-term testing results and the rapid biodegradability of the substance.

 

Toxicity to aquatic algae and cyanobacteria

An algal growth inhibition test was conducted to determine the effect on the growth of algae of the test material DEGDB (HLS 2001, VCL265/974223). The study was conducted according to EC, OECD, and US EPA test guidelines, and in compliance with GLP.

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 NOELR were 2.2 mg/L and 1.0 mg/L, respectively.

Toxicity to aquatic plants other than algae

No data available. No data required.

Toxicity to microorganisms

An activated sludge respiration inhibition test was conducted to determine the effect on sewage micro-organisms of the test material DEGDB (HLS 1998, VCL245/970386). The study was conducted in accordance with EC, OECD, and US EPA test guidelines, and in compliance with GLP.

DEGDB had no significant inhibitory effect on the respiration rate of activated sludge at any of the concentrations employed in the tests. The EC20 and EC50 of the test material could not therefore be calculated but these must be greater than 100 mg/L, the highest tested level.

A second study that supports these results was performed to assess the effect of DEGDB on the growth of the bacteria Pseudomonas putida (Safepharm 1998, 1104/002). The method followed that described in the German Water Hazard Classification Scheme Bewertung Wassergefahrdender Stoffe LTWS Nr 10 and ISO 10712, and was conducted to GLP.

Exposure of Pseudomonas putida to DEGDB gave EC10 and EC50 values of greater than 10 mg/L. The "no-observed effect level" (NOEC) was >= 10 mg/L.

Toxicity to other microorganisms

No data available. No data required.

Conclusion

The acute toxicity to aquatic organisms was investigated in (i) freshwater fish (2 species), (ii) in Daphnia magna and (iii) in green algae.

The results were as follows:

(i). The 96h LL50 to freshwater fish was determined to be 2.9 mg/L.

(ii). The 48 hour EL50 (EC50) immobilisation of Daphnia magna was determined to be 6.7 mg/L.

(iii). For algal growth inhibition, Selenastrum capricornutum, the 72h EL50 was 11 mg/L and 5.2 mg/L for growth rate and area under the curve (biomass), respectively. The "no-observed effect loading rate" (NOELR) at 72 hours was 2.2 mg/L and 1.0 mg/L for growth rate and area under the curve (biomass), respectively.