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PBT assessment

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PBT assessment: overall result

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

PBT/vPvB criteria and justification

Persistence Assessment

Stearamide is readily biodegradable in accordance with the definition given in the OECD Guidelines for the Testing of Chemicals.

Therefore, Stearamide is not persistent and does not meet the P criterion.

 

Bioaccumulation Assessment

In contrast to a calculated log KOW of 6.7, which indicates a potential of the substance to bioaccumulate, a real bioaccumulation potential in the aquatic environment is not expected.

Due to the very low water solubility (< 0.1 mg/L) of stearamide and the ready biodegradability it is not likely that the substance can be found in the aquatic environment at high concentrations. Data from acute and chronic studies indicate that the substance is not toxic to aquatic organisms (algae, daphnia, fish) in the range of water solubility. Additionally, a bioaccumulation test is technically hardly feasible due to the high insolubility of the test substance and is not necessary due to the nonhazardous character of the test substance.

Additional information about this endpoint could be gathered through BCF calculation using BCFBAF (v3.00), a subroutine of the EPI Suite™ computer program. The BCF estimated value, based on whole body wet weight, was 513, which is clearly below the trigger value of a BCF of greater than 2000.

In conclusion, Stearamide does not meet the B criterion.

 

Toxicity Assessment

Stearamide shows no toxicity in the range of water solubility.

All data give comparable results for fish, invertebrates and aquatic plants.

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Therefore, stearamide does not meet the T criterion

8.1.2. Summary and overall conclusions on PBT or vPvB properties

Overall conclusion: Stearamide is no PBT or vPvB candidate substances