Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reactive Blue 49 (meta) (boundary composition of the substance)
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Reactive Blue 49 (meta) (boundary composition of the substance)
PBT status:
the substance is not PBT / vPvB

The PBT assessment of the assessed substance is based on the analogue approach, where the source chemical (i.e. FAT 41001) is the multiconstituent of meta and para isomers of Reactive Blue 049.

1. Persistence Assessment:

Based on the data of two tests (Ready biodegradability test - Modified MITI - ISO 5815; and Inherent biodegradability – Zahn-Wellens -OECD TG 302 B) the source substance FAT 41001 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 FAT 41001 at pH 4.0 and 25 °C was estimated to be hydrolysed relatively slow (t1/2 (25 °C) = about 126 days) and stable at pH 7 and 9.

2.Bioaccumulation Assessment:

The partition coefficient n-octanol/water of the source substance FAT 41001 at 20 °C, was determined to be log Pow = - 3.88

based on the individual solubility in water and n-octanol. According to the screening criteria for bioaccumulation (B for bioaccumulative, vB for very bioaccumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log Kow ≤ 4.5. The octanol-water partition coefficient for the source substance is: log Pow = - 3.88. This value is much below the threshold value of log Kow ≤ 4.5. Considering the low water solubility and the influence of lipid solubility on the bioconcentration of hydrophobic compounds demonstrating a decrease in lipid solubility with increasing Kow values (Chessells et al. (1992)) for superhydrophobic compounds (log Kow > 6), it can be assumed that it will led to reduced BCFs. In conclusion, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.

3.Toxicity Assessment:

No long-term studies for marine or freshwater organisms are available.

According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfil the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. For the substance under consideration, the following EC50/LC50 values were obtained: Aquatic toxicity studies in Fish, Invertebrates, plant and Microorganisms were performed as per standard guidelines to evaluate the toxicity potential of the source substance the test substance. Aquatic toxicity studies in Fish were performed and the LC50 value noted at the end of 96 hour exposure period to the test substance was 140 mg/L. Toxicity to Daphnia showed an 48 hour EC50 value of >100 mg/l and toxicity on Lemna minor was also found to be >100 mg/L.

For microorganisms, studies conducted using sludge from a domestic wastewater treatment plant reported under the test conditions, the 3 h IC50 as > 320 mg/L.

Based on the test data for all the three species (LC50 and EC50>100 mg/L) the source substance FAT 41001 can be classified as Not Toxic to aquatic organisms.

There is no evidence of chronic toxicity from the available combined repeated dose and reprotoxicity/developmental screening study (OECD 422). Based upon the results obtained in this study, the "no-observed-adverse-effect level" of the source substance FAT 41001/H is 1000 mg/kg body weight for male and female rats when administered orally by gavage. The source substance is neither classified as carcinogenic, mutagenic or toxic for reproduction.

Therefore, based on current knowledge, the substance does not fulfil the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.