Reaction mass of 1,5-dihydroxy-4-nitro-8-(phenylamino)anthraquinone and 1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone

PBT assessment

PBT assessment: overall result

Reference

Name:

Disperse Blue 054 / 077

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

Disperse Blue 054 / 077

Reference substance:

Disperse Blue 054 / 077

PBT status:

the substance is not PBT / vPvB

Justification:

Persistency assessment

Based on experimental data the test substance FAT 92504 can be concluded to be not-biodegradable and stable in the environment. A hydrolytic stability test, performed as a function of pH in aqueous solution according to OECD guideline 111 method C.7(440/2008) concluded that substance the FAT 92504 is likely to not hydrolyse but show a tautomeric relationship between the keto-enol and the amino-imine and thus after an initial loss of the test item a tautomeric equilibration is observed. Due to the mechanism observed the half-life determination was beyond the scope of the method and therefore no hydrolysis rate could be calculated. Hence, the test substance can be assumed to be hydrolytically stable. The biodegradability of FAT – 92504/A was determined in a 28-days Modified MITI (II) test according to the OECD Guideline 302 C. The test substance was tested in concentration of 47.10 mg ThoD/30 mg. Mean value of biodegradation of FAT 92504/A 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 in a study conducted according to OECD Guideline 107. The partition coefficient was estimated from the saturation concentrations in n-octanol and water estimated using the flask method. The partition coefficent n-octanol/water of the test item at 20 °C, from the individual solubilities in water and n-octanol, was determined to be Pow = 12691 (log Pow = 4.10). The low log Kow (<4.5) of FAT 92504, point to the conclusion that FAT 92504 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 96-hour LC50 of the test substance was determined to be 462 mg/L. The EC50 and EC100 values were found to be higher than 100 mg/L, in a short term toxicity study with daphnids. Exposure of FAT 92504 to Lemna minor did not produce any toxic effects at saturation concentration following 7-days exposure. Based on the above details, it is evident that the LC50 values are >100 mg/L at all three trophic levels. Hence, the substance does not fulfill the T criterion.