Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

The test substance is with high probability acutely not harmful to fish. No toxic effects occur within the range of water solubility.

Key value for chemical safety assessment

Additional information

Acute toxicity of the mixture to aquatic organisms is derived from ecotoxicological information about the end-product and the by-product.

One GLP study according to OECD guideline 203 (1984) was performed with the end-product (including the impurity exceeding 1%). No mortality was observed with the carps during the study.

Two non-GLP static tests were performed with the major by-product, according to DIN 38412 (Teil 15). The LC50 was determined to be higher than 500 mg/L for both experiments.

Toxicity to fish is therefore not expected for the test substance.

Reasons for read-across:

The substance was not tested for short-term toxicity to fish. The test substance is a mixture which consists mainly of the end-product (approximately 50%) and a by-product (approximately 30%) as well as of different impurities and isomers of the end-product (one exceeding 1%). Therefore, information about short-term toxicity to fish are derived from studies performed with the end-product (including the impurity exceeding 1%), and the by-product.

 

Performance and observations:
A GLP-compliant study was performed according to OECD guideline 203 (1984) with Cyprinus carpio. A water accommodated fraction from 100 mg/L of the end-product was prepared. Seven fish were exposed to the unfiltered solution. Its measured concentration was 60-69 mg/L during the treatment period. The preparation formed a stable dispersion under the test conditions. A second group was treated with a filtered solution. Prior to use, it was passed through a filter of 5 μm pore size. A concentration of 14 mg/L was determined at the beginning of the study. It decreased to 0.85 mg/L after 96 h of exposure. No mortality was observed during the study. The LC0 and the LC50 (96h) are both higher than 100 mg/L, according to nominal concentrations at the beginning of the study.

 

Short-term toxicity of the by-product was evaluated with 2 non-GLP studies, according to DIN 38412 (Teil 15), with Leuciscus idus melanotus.

The LC50 was determined to be higher than 500 mg/L during both studies.

 

Discussion:
The end-product as well as the by-product are not toxic to fish over an exposure period of 96 h.

Toxic effects to fish are therefore not predicted for the test substance.