Registration Dossier
Registration Dossier
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EC number: 218-524-5 | CAS number: 2172-33-0
Endpoint summary
Administrative data
Description of key information
Vat Orange 011 is considered to be non-toxic to fish, Daphnia magna and microorganisms.
Additional information
The physico-chemical tests with the test substance demonstrated a very poor water solubility of the test substance with an overall solubility of less than1 µg/L. From a regulatory point of view tests on toxicity to the aquatic environment do not need to be performed. Nevertheless, toxicity tests with fish, Daphnia and microorganisms have been performed in the past.
A study performed in 1984 to determine the acute toxicity of FAT 46014 in fish following guideline similar to OECD test guideline 203, reported an LC50 >1000 mg/L.
In the study conducted according to EU Method C.2, exposure of Daphnia magna to the test item FAT 46014/G gave EC50 and EC100 value of greater than 17.1 mg/L (highest tested concentration) at 48h. The No Observed Effect Concentration was 17.1 mg/L at 48 h of exposure.
In accordance with Column 2 of Annex VII of the REACH Regulation, the toxicity testing with aquatic algae does not need to be conducted if the substance is highly insoluble in water. The solubility of FAT 46014/I was found to be below <1 µg/L. An OECD and GLP study was planned to assess the toxicity effect of FAT 46014/I on the aquatic algae. However, the substance was difficult to get into solution even at 1 µg/L under testing conditions. Hence, based on the poor solubility of the substance, testing was considered to be not feasible.
In the study conducted to determine the toxicity of FAT 46014/G to activated sludge in a 3-hour respiration inhibition test according to the OECD Guideline No. 209, the IC50 (3 h) was found to be greater than 320.0 mg/L.
Based on the above discussion, FAT 46014 is considered to be non-toxic to fish, Daphnia magna and microorganisms.
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