Registration Dossier
Registration Dossier
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EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-2
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The 96h LC 50 of >1.0 mg/l is greater than the solubility of the substance.
Key value for chemical safety assessment
Additional information
In a 96-hr acute toxicity study, using 40 rainbow trout ( Salmo gairdneri), under semi-static conditions (HRC 1989, report YKG 22 (c)), there were no mortalities or other marked reactions to exposure in 40 fish exposed to a test concentration of 1.0 mg/1 for a period of 96 hours. 1.0 mg/1 was the highest test concentration that could be prepared due to the limited solubility of the test material in water and having regard to the amount of auxiliary solvent permitted under OECD Guideline No. 203. The 96 -h LC50 and NOEC values were higher than 100 mg/L, based on mortality. The toxicity study is classified as acceptable and fully satisfies the guideline requirement for short-term toxicity to fish.
A 21 -day prolonged toxicity study conducted in accordance with OECD guideline 204 is also available. This is in effect a prolonged acute toxicity study with fish mortality as the major endpoint examined and according to ECHA Guidance Chapter R.7b, Nov 2012 page 26, R7.88.3.1, such a study cannot be considered to be a suitable long term test. In this study no mortality or other adverse effects were observed in rainbow trout exposed to a range of test concentrations of Black 400 (0.0067 - 0.94 mg/1) for a period of 21 days (10 animals per test concentration). Higher exposure levels could not be tested due to the limited solubility of the test substance in water and having regard to the limited amount of auxiliary solvent permitted in the test. The no-observed effect level was greater than the >0.94 mg/l and the LC50 must also be greater than this value. The toxicity study is classified as acceptable and fully satisfies the guideline requirement for short-term toxicity to fish.
The data from these two studies clearly show that there is no acute toxicity of Black 400 to fish at or below its solubility in water.
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