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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

1.Persistence Assessment:

Based on experimental data the test substance FAT 40061 is considered to be not-biodegradable and stable in the environment. A hydrolytic stability test as a function of pH in aqueous solution was performed according to OECD guideline 111 method C.7(440/2008). Results indicated that substance FAT 40061 was hydrolysedrelatively slow (t1/2 (25 °C) = about 220 days) at pH 9.0 (25 °C) and stable at pH 4 and 7.

2.Bioaccumulation Assessment:

The partition coefficient n-octanol/water of FAT 40061 at 20 °C, calculated from the individual solubility in water and n-octanol, was determined to be log Pow = - 4.74. 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 test item is log Pow = -4.74

This value is much below the threshold value of log Kow ≤ 4.5. Considering the low water solubility value and further looking at the influence of lipid solubility on the bioconcentration of hydrophobic compounds and demonstrated 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/L50 values were obtained: Aquatic toxicity studies in fish, invertebrates, algae and mMicroorganisms were performed according to standard guidelines to evaluate the toxicity potential of the test 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 570 mg/L. Toxicity to daphnids showed 48 hour EC50 value as > 180 mg/l and toxicity on algae 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) FAT 40061 can be classified as non-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 FAT 40061 is 1000 mg/kg body weight for male and female rats when administered orally by gavage. The 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.