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PBT assessment

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PBT assessment: overall result

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

1.Persistence Assessment:

Based on the data of two tests (Ready biodegradability test - Modified MITI -OECD TG 301 C; and Inherent biodegradability – Zahn-Wellens - (OECD TG 302 B ) the test substance FAT 36014 can be concluded to be not-biodegradable and stable in environment. Data on the biodegradation in the sediment and soil compartments are lacking. Therefor, the test item should be considered as not biodegradable. The substance is hydrolytically stable under basic, neutral and acidic environmental conditions. The hydrolytic stability test, abiotic degradation of FAT 36014/Z as a function of pH in aqueous solution performed according to OECD guideline 111 method C.7(440/2008) concluded that the test item would be stable towards hydrolysis at pH 4, 7 and 9. Photodegradation in air is not a relevant degradation process for this substance since the test item has negligible vapour pressure and atmospheric release in form of fumes or aerosols is unlikely with regard to the identified use patterns. There is no information available about photodegradation of the substance in sediment or soil. Also the adsorption to soil and sludge was tested using the HPLC method, the outcome indicates that the test substance does not sorb strongly to soil and sludge and can be regarded as mobile.

2. Bioaccumulation assessment:

The partition coefficient n-octanol/water of the test item at 20 °C, from the individual solubility in water and n-octanol, was determined to: log Pow = 2.69.

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 Kow = 2.69. 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 (test substance: log Kow >6.2). 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: fresh water Lemna growth rate based on loading rate EC10 >31.1, NOEC 31.3, LOEC 100; and based on actual concentration EC10 is 0.409, NOEC 0.313 LOEC 2.0; The substance is neither classified as carcinogenic, mutagenic or toxic for reproduction. There is no evidence of chronic toxicity from the available 28-day repeated dose mammalian toxicity test. No sub-chronic or chronic repeated dose toxicity studies are available. 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.