Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

PBT assessment

PBT assessment: overall result

Reference

Name:

Reactive Blue 069

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

Reactive Blue 069

PBT status:

the substance is not PBT / vPvB

Justification:

Persistency assessment

Based on experimental data the test substance FAT 92349/B can be concluded to be not-biodegradable and stable in the environment. In a hydrolytic stability test, FAT 92349/B was found to be hydrolytically stable, i.e., a half-life of greater than 1 year at 25 °C, at pH 4 and 7. In an inherent biodegradability test conducted with FAT 92349/A, the bioelimination of the test substance after 28 days was determined to be 0 %. Hence, based on the available data the substance may meet the P and/or vP criterian.

Bioaccumulation assessment

The partition coefficient of the test substance was determined to be 0.00047 (log Kow = -3.33). The low log Kow in combination with high water solubility of FAT 92349/B, point to the conclusion that FAT 92349/B is neither bioaccumulative (B) nor very bioaccumulative (vB).

Toxicity assessment

The substance is not classified as carcinogenic, mutagenic or reprotoxic according to Regulation EC 1271/2008. No long-term studies for marine or freshwater organisms are available. However, aquatic toxicity potential of substance FAT 92349/B was evaluated in studies conducted with fish, invertebrates, plants (Lemna) and bacteria. In an acute fish toxicity study conducted according to an internal Ciba guideline equivalent to OECD Guideline 203, the LC50 of the test substance was determined to be 140 mg/L. The EC50 and EC100 values were found to be higher than 194.6 mg/L, in a short term toxicity study with daphnids. The EC50 following 7-days exposure of Lemna minor to the test item, was determined to be (response variable: average specific growth rate, measurement variable: frond number) >100 mg/L, while the NOEC and LOEC were 32 and 65 mg/L, respectively. Based on the above details, it is evident that the LC50 values are >0.01 mg/L at all three trophic levels. Hence, the substance does not fulfil the T criterion.