Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish: Key study: Test method OECD 203. GLP study. The 96h-LL50 was determined to be > 1000 mg/L nominal WAF in Sheepshead minnow.

Long-term toxicity to fish: Data waiving (other justification): In accordance with column 2 of REACH Annex IX, the study does not need to be conducted since the chemical safety assessment indicates the no need to investigate further the effects on aquatic organisms.

Short-term toxicity to aquatic invertebrates: Key study: Test method EC C2, OECD 202. GLP study. The 48h-EL50 of the substance was determined to be 40.46 mg/L nominal loading rate in Daphnia magna.

Long-term toxicity to aquatic invertebrates: Data waiving (other justification): In accordance with column 2 of REACH Annex IX, the study does not need to be conducted since the chemical safety assessment indicates the no need to investigate further the effects on aquatic organisms.

Toxicity to aquatic algae and cyanobacteria: Key study: Test method EC method C.3, OECD 201. GLP study: The 72h-EL50 of CNSL was determined to be 5.82 mg/L loading rate (basis for effect: growth rate) in green algae. The 72h-EL10 was 1.34 mg/L and 72h-NOELR was 1 mg/L.

Toxicity to microorganisms: Data waiving (study technically not feasible): Due to the low solubility of the substance (0.2-0.4 mg/L) the study was technically not feasible. Supporting study: Test method EC C.4-D, OECD 301F. GLP study. The 28d-NOEC for activated sludge of the test item was determined to be 100 mg/L loading rate (based on biodegradation).

Additional information

Discussion:

Due to data sharing obligation and following ECHA’s indications, the registrant Wave S.L. has been forced to acquire robust study summaries for acute toxicity to fish from CNSL Consortium. This registrant is not allowed to perform studies in vertebrates without Authorities’ permission under risk to breaching Directive 2010/63/EU of The European Parliament and of The Council of 22nd of September 2010 regarding the protection of animals used for scientific purposes which prohibit duplicate testing.

CNSL Consortium didn’t allow the registrant to get access to full study report for quality evaluation and/or proper substance identification. Consequently the present REACH registration dossier contains the available information owned by CNSL Consortium.

CNSL Consortium performed an acute toxicity to Sheepshead minnow (Cyprinodon variegatus) according to OECD Guideline 203. The 96h-LL50 was determined to be > 1000 mg/L nominal WAF. No sign of toxicity were noted. Nevertheless, it should be pointed out that no analytical monitoring was performed. The concentration, homogeneity and stability of the test material in the test preparations were not determined.

The registrant Wave S.L. performed an acute immobilisation test on Daphnia (Daphnia magna) (OECD Guidance 202, GLP study) and a growth inhibition test on algae (Pseudokirchneriella subcapitata) (OECD Guidance 201, GLP study) with its own substance. Taking into account that the substance is an UVCB substance, test concentrations were prepared according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23 prior to treatment. The duration of the mixing and settling phases were determined by carrying out a preliminary study. Test concentrations were analytically determined at the beginning of the test and 24-hour intervals thereafter during the experiment in order to demonstrate attainment of equilibrium in WAF preparation and stability during the test. The 48h-EL50 was determined to be 40.46 mg/L nominal loading rate in Daphnia magna. The 72h-EL50 (growth rate) of the substance was determined to be 5.82 mg/L loading rate in green alga Pseudokirchneriella subpicata. The 72h-EL10 was 1.34 mg/L and 72h-NOELR was 1 mg/L.

Based on these results, the substance is classified as Hazardous to the aquatic environment, Chronic category 3, according to CLP Regulation (EC) no. 1272/2008, since the NOELR (72h) for algae was 1 mg/L and the 48h-EL50 for daphnia was in the range of 10 -100 mg/L. The substance is considered as readily biodegradable and the partition coefficient was determined to be higher than 4.

On the other hand, according to the information published by ECHA, CNSL Consortium performed an acute lethal toxicity test with marine copepods (ISO Now ISO 14669, GLP study) and a marine algal growth inhibition test with Skeletonema costatum and Phaeodactylum tricornutum (ISO 10253, GLP study). In either study the analytical monitoring was not performed. The 48h- LL50 was >1000 mg/L nominal WAF in marine copepods and the 72h-EC50 (growth rate) was 1300 mg/l WAF loading rate in algae. CNSL Consortium did not classify the substance for aquatic toxicity.

The results obtained by the registrant Wave S.L. and CNSL Consortium are not consistent. Therefore, it can be concluded that the test items are toxicologically different.