Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Acute data of variable reliabilities (Klimisch rating), based on international guidelines, are available for three trophic levels: Algae, Invertebrates and Fish and are summarised in the table below.

Level of exposure / trophic levels

Organism

EC50/LC50

NOEC

Flag / reliability

Performing laboratory

Reference in IUCLID

Acute / Aquatic algae

Scenedesmus subspicatus

96h: >3.73 mg/L

96h: ≥ 3.73 mg/L

K/2

CIT

Toxicity to aquatic algae and cyanobacteria, CIT, 2000, K

Acute / Aquatic invertebrates

Daphnia magna

48h: >3.16 mg/L

Not relevant

K/2

CIT

Short-term toxicity to aquatic invertebrates, CIT, 2000, K

Acute / Fish

Oncorhynchus mykiss

96h: 1.6 mg/L

 Not relevant

K/1

SafePharm

Short-term toxicity to fish, Safepharm, 2003, K

Acute / Fish

Oncorhynchus mykiss

96h: 1.26 mg/L

Not relevant

S/3

CIT

Short-term toxicity to fish, CIT, 2000, S

Acute / Micro-organisms

activated sewage sludge

3h: >100 mg/L

3h: ≥100 mg/L

K/2

CIT

Toxicity to microorganisms, CIT, 2000, K

Among all data available, the fish Oncorhynchus mykiss seems to be the most sensitive species with a 96h-LC50 at 1.6 mg/L.

No toxicity was observed on the algae Scenedesmus subspicatus and on the aquatic invertebrates Daphnia magna up to the highest attainable concentration, measured at 3.73 mg/L for algae test and 3.16 mg/L for daphnia study. No toxicity was observed on micro-organisms of a water treatment plant up to 100 mg/L (nominal concentration).

 

Care must be taken from CIT studies (algae, aquatic invertebrates and fish studies). The analytical methodology of these studies is not adapted and is insufficient to measure with precision the concentrations tested. No submission of other studies was proposed because one valid study is available to assess the acute toxicity of the most sensitive species: fish.

In accordance with column 2 of REACH annex IX, further testing on the long-term effects on aquatic organisms does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.

Additional information