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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 36002 can be concluded to be not-biodegradable and stable in the environment. Due to the low water solubility (< 1.0 μg/l) to conduct the hydrolysis experiment was not feasible.

2.Bioaccumulation Assessment:

The partition coefficient n-octanol/water of the test item at 20 °C was calculated from the individual solubility in water and n-octanol and was determined to be: log Pow = > 6.1

This value is much higher than 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 not vB criterion.

 

3.Toxicity Assessment:

The substance is not harmful or toxic upon oral ingestion as demonstrated by acute oral tests. The substance is not classified as carcinogenic, mutagenic or reprotoxic according to Regulation EC 1271/2008.

There is no evidence of chronic toxicity from the available read across (FAT 92504) oral Combined Repeated Dose Toxicity Study in rats (OECD 422). Based upon the results obtained in this study, the "no-observed-effect level" is determined to be 1000 mg/kg body weight for female rats when administered orally by gavage.

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 fulfill 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. Physico-chemical tests with the test substance demonstrated a very poor water solubility of the test substance with an overall solubility of less than 1 ug/L. From a regulatory point of view tests on toxicity to the aquatic environment do not need to be performed.

Nevertheless, toxicity tests to fish have been performed in the past. A study performed in 1987 to determine the acute toxicity of FAT 36002 as isomeric mixture in fish following guideline similar to OECD test guideline 203 using Zebra fish reported an LC50 >100 mg/L. Toxicity to daphnids showed 48-hour EC50 value of >100 mg/l

As an overall result and due to the poor water solubility, toxicity to aquatic algae caused by the test substance could not be demonstrated as the test was not conducted. Because of poor water solubility it was decided not to further test for toxicity to aquatic plant.

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

No long-term studies for marine or freshwater organisms are available. Therefore, based on current knowledge, the substance does not fulfill the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.

In the absence of long-term studies for marine or freshwater organisms, based on the available acute test data for fish, daphnia and microorganisms (least LC50 value noted in fish and daphnia study is > 100 mg/L) FAT 36002 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.