Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute toxicity to fish:

In an OECD 203 study, conducted to GLP, based on the mean measured test concentrations of the centrifuged test media the acute toxicity of the test material to rainbow trout, methylene bis(dibutyldithiocarbamate) gave a 96-Hour LC50 value of greater than 0.060 mg /L. The NOEC was 0.060 mg/L (Safepharm Laboratories, 2004).

No mortality was observed during the test. The test was conducted using dimethylforamide to pre-dissolve the test material before dilution in test media. When analysed test concentrations were far lower than what was theoretically created, indicating that there were difficulties stemming from water solubility of the test material. The test material is known to possess low water solubility (0.243 mg/l at 20 ± 5 ºC). In the absence of any evidence of toxicity, and taking into consideration the difficulties in water solubility, it is considered that no evidence of toxicity is seen at the limit of solubility.

Chronic toxicity to fish:

Upon review of the methylenbis(dibutyldithiocarbamate) acute ecotoxicity data, the NOEC results to aquatic invertebrates (0.052 mg/l) and fish (0.06 mg/l),Daphnia magnaare considered the most sensitive species in terms of aquatic testing. To avoid unnecessary testing the most sensitive species can be chosen as the most appropriate species for long term testing. According to Column 2 of Annex IX of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1907/2006 regulation the choice of appropriate testing depends upon the results of the chemical safety assessment. Based on acute aquatic results for methylenbis(dibutyldithiocarbamate)daphnia magnaare the more sensitive species and thus will yield sufficient conservative results to quantify the potential hazards of the test substance while also providing an appropriate hazard assessment. Chronic testing is available with the most sensitive speciesdaphnia magna, therefore, chronic testing of fish is being waived.

Acute toxicity to daphnia:

In an OECD 204 study, conducted to GLP, the 48-HourEC50 of methylenbis(dibutyldithiocarbamate) (centrifuged test media) todaphnia magna is greater than 0.052 mg/L (mean measured) and correspondingly the NOEC was 0.052 mg/L (Safepharm Laboratories, 2004).

No mortality was observed during the test. The test was conducted using dimethylforamide to pre-dissolve the test material before dilution in test media. When analysed test concentrations were far lower than what was theoretically created, indicating that there were difficulties stemming from water solubility of the test material. methylenbis(dibutyldithiocarbamate) is known to possess a low water solubility (0.243 mg/l at 20 ± 5 ºC). In the absence of any evidence of toxicity, and taking into consideration the difficulties in water solubility, it is considered that no evidence of toxicity is seen at the limit of solubility.

Chronic toxicity to daphnia:

In an OECD 211 study, conducted to GLP, the 21-day toxicity toDaphnia Magna NOEC and MATC of 4,4'-methylene bis(dibutyldithiocarbamate) was determined to be greater than 247 μg/L.

As the NOEC was 0.247 mg/l at 21 days, it is considered that there is no toxicity at the limit of water solubility (water solubility; 0.247 mg/l at 20 ± 5 ºC) (Harlan Laboratories, 2009).

Acute toxicity to algae:

In an OECD 201 study, conducted to GLP, the 72-Hour EC50 of methylenbis(dibutyldithiocarbamate) (centrifuged test media) toScenedesmus subspicatus is greater than 0.0325 mg/L (mean measured) and correspondingly the NOEC was 0.0325 mg/L (Safepharm Laboratories, 2004).

No mortality was observed during the test. The test was conducted using dimethylforamide to pre-dissolve the test material before delusion in test media. When analysed test concentrations were far lower than what was theoretically created, indicating that there were difficulties stemming from water solubility of the test material. The test material is known to possess a low water solubility (0.243 mg/l at 20 ± 5 ºC). In the absence of any evidence of toxicity, and taking into consideration the difficulties in water solubility, it is considered that no evidence of toxicity is seen at the limit of solubility.

Activated Sludge Respiration Inhibition:

In an OECD 209 study, conducted to GLP, methylenbis(dibutyldithiocarbamate) was not toxic to waste water (activated sludge) bacteria at or below a loading rate of 1000 mg/L (NOEC). The EC50 exceeded a loading rate of 1000 mg/L (WIL Research Europe, 2013).