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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

EC50 (48 h) = 1.03 mg/l

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1.03 mg/L

Additional information

No studies on "aquatic toxicity" are available for the Target Substance. In order evaluate the invertebrates toxicity endpoint a read-across approach was adopted. Tests on two Similar Substances are available. The similarity between the Target Substance and the Similar Substances is detailed in section 13.

In the key study the substance (Similar Substance 02) was tested for short-term toxicity on freshwater invertebrates according to the guideline OECD 202 (1984) and Royal Decree 363/1995 (BOE no.133 of June 1995).
The freshwater crustacean Daphnia magna has been subjected to the dye at concentrations of: 0.1mg/l, 1 mg/l, 10 mg/l, 100mg/l and 1000 mg/l of active ingredient of that product. The total test duration was 48 hours.
The result obtained in this test indicates that the dye had a nominal value of EC50 (48 h) equal to 1.03 mg/l.

One more study is available on Similar Substance 03. It reported an EC50 (24 h) higher than 500 mg/l. However, it should be noted that the study was conducted only for 24 instead of 48 hours, duration of exposure suggested by the internationally recommended guidelines. The difference in time of exposure is certainly a critical effect, especially when assessing exposure to an invertebrate organism with a relative short life-cycle such as Daphnia. Furthermore, considering the potentially highly variable ecotoxicological profile of dye substances, the present deviation was considered to be a significant deficiency. Therefore, the result of the test was disregarded.