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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 experimental data the test substance FAT 40032 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 the test substance FAT 40032 to be hydrolytically stable, i.e., a half-life of greater than 1 year at 25 °C, at pH 7 and 9, whereas at pH 4 the estimated rate constant was 1.46 X 10 -6 with half-life of 198 days.

 

2.Bioaccumulation Assessment:

The adsorption/desorption screening test does not have to be conducted as FAT 40032 has a low octanol water partition coefficient (log Pow -5.57). Log Kow calculated using EPA ECOSAR is 3.126. 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 = 3.126

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:

The substance is not harmful or toxic upon oral ingestion as demonstrated by acute oral tests. Also, no acute systemic toxicity was observed when the substance was applied to the skin or the mucosa of animals for tests on skin and eye irritation, whereas the test substance was found to be skin sensitizer.

There is no evidence of chronic toxicity from the available read across (FAT 40827) oral repeated dose toxicity study is in rats (OECD 407). Based upon the results obtained in this study, the "no-observed-effect level" of FAT 40032 is 1000 mg/kg body weight for rats when administered orally by gavage.

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. 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.

 

According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance must 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.

Aquatic toxicity studies in fish, invertebrates, algae and microorganisms were performed as per standard guidelines to evaluate the toxicity potential of the test substance the test substance. For all the three tropic levels (fish, invertebrates and aquatic plants) EC50/LC50 >100 mg/L. 

For microorganisms, studies conducted using activated sludge from a domestic wastewater treatment plant reported an 3 h IC50 of >400 mg/L.

 

Based on the test data for all the three trophic levels FAT 40032 can be classified as 'not-toxic' to aquatic organisms according to GHS and the T-criterion is not fulfilled according to the screening criteria provided by ECHA.