Registration Dossier
Registration Dossier
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EC number: 946-373-1 | CAS number: 82941-24-0
Endpoint summary
Administrative data
Description of key information
LC50 (96 h) in fish (Leuciscus idus) < 1 mg/l.
EC50 (48 h) in aquatic invertebrates (Daphnia magna) < 1 mg/l.
EC50 (96 h) in algal cells = 2.91 mg/l (growth rate)
EC50 in microorganisms = 31 mg/l.
Additional information
Assessment on aquatic toxicity of Basic Blue 026 leuco relied on information of the substance itself, possibly completed by data on read across substances. A detailed justification of the read across strategy is attached in section 13.
In available studies, exposure to test substance was reported in terms of nominal concentrations. No indication of composition and possible precipitation and/or degradation of tested substance was reported.
Fish
Similar substances were tested for acute toxicity to fish in 96 -hour static studies, based on DIN 38412 guideline (L1 and L15); observations for mortality were done at 1, 4, 24, 48, 72 and 96 h after start of exposure.
In particular, similar substance 1 was tested using 8 concentrations in the range 0.01 - 2.15 mg/l and controls, with 10/fish/concentration; Similar Substance 01 was tested using 7 concentrations in the range 0.01 - 1.0 mg/l and controls, with 10/fish/concentration.
Both substances showed LC50 values below 1 mg/l, as nominal concentrations.
Aquatic invertebrates
In available studies, similar substances were tested for acute toxicity to aquatic invertebrates up to 48 -hour, based on DIN 38412 guideline; observations for effects on mobility were done at 3, 6, 24 and 48 h after start of exposure.
Similar substance 01 was tested under static exposure conditions, using 9 concentrations in the range 0.0975 - 25 µg/l and a control, with 20 animals per concentration divided in 4 replicates. Similar Substance 3 was tested using 8 concentrations in the range 2 - 100 µg/l and a control, with 2 replicates per concentration.
Both substances showed EC50 values below 1 mg/l, as nominal concentrations.
Aquatic algae and cyanobacteria / aquatic plants
Similar Substance 02, it was tested for toxicity to aquatic algae in a 96 -hour test, based on DIN 38412 L9 guideline; observations for effect on growth rate and cell count were carried out at 0, 24, 48, 72 and 96 h after start of exposure. The substance was tested at 6 concentrations in the range 1 to 50 mg/l and EC50 values were determined for growth rate and cell count in the range between 1 and 10 mg/l.
Few details on the study on Similar Substance 03 were available. After a 72 -hour exposure, an EC50 value of 3.6 mg/l was found for growth rate.
Microorganisms
Few details on the study were available. The potential toxicity of the substance to microorganisms was assessed considering the oxygen consumption, leading to EC10 = 4 mg/l, EC50 = 31 mg/l and EC90 > 50 mg/l.
Testing procedures and results were not well detailed. Therefore, this result could only be considered as a qualitative indication of toxicity.
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.
Despite the lack of details, available studies were indicative of a high toxicity of the substance. Indeed, 50 % of effect in terms of mortality in fish and immobilisitation in daphnia was seen at concentrations well below 1 mg/l, i.e. relevant for classification. Specifically, LC50 (96h) in fish was identified at 0.158 mg/l and EC50 (48h) in daphnia was identified at 3.68 µg/l.
As for algal cells, lower toxicity was found, leading to an EC50 (96 h) of 2.91 mg/l for growth rate.
Based on results with fish and daphnia, classification for acute aquatic toxicity was applied.
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 available results, classification for chronic aquatic toxicity in cat. 1 was applied according to the CLP Regulation (EC 1272/2008).
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