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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint summary

Administrative data

Description of key information

LC50 (96h) in fish (Cyprinus carpio) = 46 mg/l.

EC50 in aquatic invertebrates (Daphnia magna) = 228 mg/l.

ErC50 (7d) in aquatic plants (Lemna gibba) = 66.414 mg/l.

Additional information

No data on aquatic toxicity are available on the substance under registration, thus data on the analogues Similar Substance 01 (an isomer of Direct Blue 273) and Similar Substance 02 was taken into account.

The read across approach can be considered appropriate; further details are included into the document attached in section 13.

The information on the Similar Substance 01 derived from migrated NONS file with permission to refer granted by ECHA. Details on testing method and procedures are lacking.

Short term toxicity to fish

Available data on the Similar substance 01 indicates a LC50 (96h) of 46 mg/l (nominal).

Short term toxicity to aquatic invertebrates

Experimental study conducted on Similar Substance 01 indicates an EC50 of 228 mg/l; no data about duration and type of concentration (nominal or measured) is available.

Toxicity to aquatic algae/plants

A test on toxicity to algae was carried out with Similar Substance 01. However, difference on growth rate due to direct and indiret exposure to the substance was within 10 %, thus suggesting that final result was affected by light intensity. Consequently, such study was not used in the assessement.

As Similar Substance 01, Direct Blue 273 is a dye and it could influence the photosynthesis capacity of algae cells in test solutions. Therefore, effects on algae may likely be due to such mechanism, rather than to an effective toxicity of the substance.

For this reason and in order to clarify the (eco)toxicological properties towards aquatic plants, the results of a test on Similar Substance 02, using Lemna gibba as test organism, were taken into account.

As for growth rate of frond number, an ErC50 (7d) of 66.414 (nominal) was found.

Toxicity to microorganisms

Available information on Similar Substance 01 indicates the substance as non toxic for microorganisms, with IC50 (3h) > 10000 mg/l.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), the threshold of classification of a substance for acute aquatic toxicity is 1 mg/l. This limit is compared with LC50 (96h) for fish, EC50 (48 h) for daphnia and EC50 (72 - 96 h) for algae or aquatic plants.

Toxicity to fish was assessed in a 96 -hour test and mortality was seen in 50 % of animals exposed at concentration of 46 mg/l.

The duration of the test on daphnia was not available; however, acute immobilisation was seen in 50 % of daphnia exposed at concentration of 228 mg/l.

Toxicity on lemna was assessed in 7-day test and effects on growth rate of fronds were reported with ErC50 of 66.414 mg/l.

No chronic toxicity data is available from long-term studies. In case of lack of chronic data, the potential for chronic toxicity is identified by appropriate combinations of acute toxicity data and lack of biodegradability. The threshold of classification is 100 mg/l.

Based on results obtained with fish and lemna, classification for chronic aquatic toxicity in category 3 (H412) was applied according to the CLP Regulation (EC 1272/2008).