Registration Dossier
Registration Dossier
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EC number: 945-517-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
For substances covered by Annex VII to REACH short-term toxicity testing on invertebrates (preferably Daphnia) and growth inhibition study on aquatic plants (preferably algae) are required.
The two tests required to fulfill the ANNEX VII were performed on a similar substance (read-across from supporting substance -structural analogue or surrogate).
Aquatic algae
The toxicity to aquatic algae was assessed in a a direct/indirect exposure, due to the fact that the test item is an azo dye.
Algal growth was almost completely reduced at the highest concentration of 100 mg/L after indirect exposure.
Under the conditions of the study with Selenastrum capricornutum, the similar substance affected cell growth of this fresh water algae species mainly by absorption of wavelengths necessary for algal growth, due to its dyeing properties at these concentrations (yellow to dark brown).
More than 70% of the reduction of growth rate was related to absorption of wavelengths by thecolour of the test solutions at the concentrations up to and including 100 mg/l, the maximumconcentration to be tested. Hence, the actual ErC50 exceeded 100 mg/L.
Although the ratio between growth rates under direct and indirect exposure was below 90% in 4 out of 7 concentrations, it is important to consider the fact that almost complete algal growth was induced by indirect exposure to the highest concentration.
This observation strengthens the conclusion that the major effect on algal growth is related to the dyeing properties, which overrules any intrinsic toxic effect.
Aquatic invertebrates
After a range-finding test, a limit test was performed with Daphnia Magna Strauss, exposed to a solution of 100 mg/L.
No daphnids became immobile during the 48 hour test period. Analysis of the samples taken during the limit test showed that measured concentrations werein agreement with nominal (96-97%).
Hence, the 48h-EC50 forDaphnia magna exposed to the substance was > 100 mg/L, the maximum concentration to be tested.
In addition, in order to have an overall idea of the the toxicity in the aquatic trophic level, the base set can be completed with an 96-Hour Acute Toxicity Study in Carp on the Similar substance 01, based on the EEC directive 92/69, Part C(3.1. "Acute toxicity tor fish“; and the OECD guideline No. 203: "Fish Acute Toxicity Test", Adopted 17 July, 1992.
The study defined the fish 96h-LC50 > 100 mg/L, the regulatory limit concentration.
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