Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

EC50 fish (96h): 13.8 mg/l  (QSAR predicted from category trend analysis of 12 methacrylates)  

EC50 algae (72h): 9.79 mg/l

EC10 algae (72h): 4.35 mg/l

EC10 Daphnia (21d): 7.51 mg/l

The lowest aquatic toxicity value for the read across substance 1,4-BDDMA was the 72 h-EC10 of 4.35mg/L, based on the toxicity test with the freshwater alga Desmodesmus subspicatus.

Additional information

Freshwater aquatic toxicity studies with 1,4-BDDMA and the structural analogue 1,3 -BDDMA were conducted in fish, invertebrates, algal and microbial species.

Short-term toxicity to fish

In a 48-h acute toxicity study, golden orfes (Idus melanotus HECKEL) were exposed to 1,3-BDDMA nominal concentrations of 25, 30 and 40 mg/L under static conditions. 

The 48-h EC50 was 32.5 mg/L. The 48-h NOEC was 25 mg/L.

EC50 fish (96h): 13.8 mg/l  (QSAR predicted from category trend analysis of 12 methacrylates), key study

 

Short-term toxicity to aquatic invertebrates

No experimental data on short-term toxicity of 1,4-BDDMA are available. In accordance with REACH regulation Annex VII, 9.1.1., column 1, long-term toxicity data are provided instead.Up to the highest concentration tested (30.8 mg/L) there was no mortality of the adult daphnia within the first 48 h of the daphnia reproduction study. In conclusion, the 48h EC50 for mortality was greater than 30.8 mg/L.

 

Toxicity to aquatic algae

In a 72 hour acute toxicity study, the cultures ofDesmodesmus subspicatusCHODAT SAG 86.81 were exposed to 1,4-BDDMA at measured concentrations of 0 (control), 0.828, 2.11, 5.81, 14.9 and 38.7 mg/L under static conditions in accordance with the OECD guideline 201 (adopted 23 March 2006). 

Microscopic evaluation of the cells at start and end of the incubation period revealed no morphological abnormalities.

The NOEC, EC10 and EC50 values based on growth rate were 2.11 mg/L,4.35 mg/Land9.79 mg/L, respectively. 

 

Long-term toxicity to fish

Long-term testing in fish is waived for 1,4-BDDMA since the substance is readily biodegradable. The risk characterisation shows that the PEC/PNECaqua ratio for the aquatic environment is <1, indicating no need for further information or testing. According to REACH regulation Annex IX, 9.1. column 2, long-term toxicity testing shall only be considered when the chemical safety assessment indicates the need for further investigations. Thus, no long-term toxicity testing is required for 1,4-BDDMA.

 

Long-term toxicity to aquatic invertebrates

The 21-day-chronic toxicity of 1,4-BDDMA to Daphnia magna Straus was studied under static renewal conditions according to OECD guideline 211 (adopted 3 October 2008). Daphnids were exposed to control and test chemical at measured concentrations of 0 (control),0.635, 1.81, 5.09, 13.5 and 30.8 mg/L

The 21 day EC50 based on mortality was 22.1 mg/L. The 21 day EC50 based on reproductive effects was 14.1 mg/L. The 21 d EC10 based on reproduction was7.51 mg/L.The 21-day NOEC based on reproduction was 5.09 mg/L.

The sublethal effects included were reproduction rate and appearance of first brood. Production of offspring in the treated groups indicated that 1,4-BDDMA had an effect on the reproduction at concentrations greater than 5.09 mg/L. The most sensitive end point was the reduction of the reproductive output.        

 

Toxicity to microorganisms

The toxicity of 1,4 -BDDMA (99.67% a.i.) to microorganisms was investigated during a ready biodegradation study according to OECD guideline 310 (Headspace Test), adopted 23 March 2006, over a period of 28 days and using predominantly domestic non-adapted activated sludge as inoculum.

The biodegradation rate was determined by measurement of carbon dioxide evolution. Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and toxicity control with reference substance and test substance (20 mg/L test substance) were performed.

The biodegradation of the toxicity control reached 83% within 14 d and it came to 89% after 28 d. The biodegradation of the reference item was not inhibited by the test item in the toxicity control. The 95% confidence interval on day 28 was 86 - 93%. Therefore, the test substance was assumed not to inhibit microbial activity at a concentration of 20 mg/L.

 

In conclusion, the lowest aquatic toxicity value for the read cross substance 1,4-BDDMA was the 72 h-EC10 of 4.35mg/L, based on the toxicity test with the freshwater algaDesmodesmus subspicatus.