Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Three acute studies on the different trophic levels are available on the analogue substances 1 and 2.

In particular, one acute toxicity study on aquatic invertebrates, namely Daphnia Magna, is available on analogue substance 1 (Huntsman, 1993). During the experiment, precipitation of the test item in the test medium occured and at the solubility limit of the test item under the experimental conditions the EC50, 48h is > 10 mg/l, corresponding also to the EC0 since no immobilisation was observed.

An acute toxicity to fish is also available on analogue substance 1(Huntsman, 1998) for the same analogue test item. Very low nominal concentrations were assessed, however some precipitations occured at the two highest doses and mortality was neverthless observed, showing a LC50,96h equal to 0.66 mg/l.

No acute toxicity on algae is considered since coloured substances as dyes show light absorption which have an indirect effect on the algae growth rate that is not related to the intrinsic toxicity of the substance. Therefore, following EU Commission Regulation, an acute toxicity test on Lemna minor was performed on the analogue substance 2 with the results of ECr50 = 192 mg/l (frond number and dry weight).

Table 4.1.0 of the Regulation 1272/2008 states that a substance is considered classified as hazardous to the aquatic environment in:

Category 1 Acute, if 96h, LC50 for fish and/or 48h, EC50 for crustacea and/or 72 -96h Er50 for algae or other aquatic plants < 1 mg/l and in

Category 1 Chronic if 96h,LC50 for fish and/or 48h,EC50 for crustacea and/or 72 -96h Er50 for algae or other aquatic plants are >0.1 and < 1 mg/l and the substance is not rapidly biodegradable.

Based on the results of the acute fish toxicity, on biodegradation and on the read across considerations Acid Black 164 is classified as Acute 1,H400: very toxic to aquatic life and Chronic 1 H410: T Very toxic to aquatic life with long lasting effects.