Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The aquatic toxicity assessment has been based on the Read Across approach:

Acid Red 249:1 is a multiconstituent substance composed by the acidic and the sodium salt forms of the same structure (72.7 % and 14.95 % of the substances respectively).

The tests was performed on the Similar Substnace 01 which is the major component of the multiconstituent substance. Considering the high similarity between the structures and the composition of the substance the Read Across approach is considered as acceptable. See section 13.

Fish

The determination on ecotoxicity of the substance to be registered on Zebra fish has been performed in an acute test.

The study has no indication of the method used and there are not enough information to establish if all requirements of an international accepted method are fulfilled, nevertheless the study can be considered valid.

The LC50 is > 300 mg/l at 96. This result is in agreement with studies performed on similar substances.

Invertebrates

The determination on ecotoxicity of the substance to be registered was determined in an acute test on Daphnia, according to the guideline 92/69/EEC C.2. The test has been performed in compliance with the Procedures and Principles of Good Laboratory Practice. The test substance was tested on Daphnia magna Straus 1820 for 48 hours.

20 daphnids (0-24 hours old) were exposed to nominal concentrations of 2.0, 4.4, 9.6,21,46 and 100 mg test substance respectively.

The EC50 calculated at 48 hours resulted 104 mg/l.

Aquatic plants

Acid Red 249 is a dyestuff which could influence the photosynthesis capacity of algae cells in the test solution and in order to clarify the (eco)toxicological properties related to toxicity for aquatic plants. Acid Red 249 has been tested using Lemna minor as a test organism (REACH&Colours Kft, 2015), following the the OECD guideline 221 according to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b: Endpoint specific guidance (Version 2.0 November 2014), published by the European Chemical Agency.

Under the test conditions the median effect concentrations of the substance to Lemna minor with respect to growth rate (ErC50) for the endpoint frond numbers and dry weight were estimated to be 100–1000 mg/l nominal (NOErC = ca. 10 mg/l).

Moreover the median effect concentrations of the substance to Lemna minor with respect to yield (EyC50) for the endpoint frond numbers and dry weight were estimated to be about 100 mg/l nominal concentration (NOEyC < 10 mg/l).

Microorganism

A non detailed study is available. Toxicity on STP activated sludge has been performed. The result BST was > 300 mg/l.

According to the CLP Regulation (EC) n. 1272/2008, 'acute (short-term) hazard’ means for classification purposes the hazard of a substance or mixture caused by its acute toxicity to an organism during short-term aquatic exposure to that substance or mixture.

The tests on fish and invertebrates confirm no concern for the aquatic compartment, therefore no classification is warranted under the CLP Regulation.

Based on the test conducted on the Similar Substance 01, Acid Red 249:1 is expected to be Not classified for the aquatic compartment..