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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:

Persistence Assessment

Docosanamide (CAS No. 3061-75-4) is readily biodegradable in accordance with the definition given in the OECD Guidelines for the Testing of Chemicals.

Therefore, docosanamide (CAS No. 3061-75-4) is not persistent and does not meet the P criterion.

Bioaccumulation Assessment

In contrast to a calculated log Kow of > 5.7 which indicates a potential of the substance to bioaccumulate, a real bioaccumulation potential in the aquatic environment is not expected.

Due to the low water solubility (< 0.05 mg/L) of docosanamide (CAS No. 3061-75-4) and the characteristics that the substance is readily biodegradable it is not likely that it can be found in the aquatic environment in high concentrations. Data from acute and chronic studies afford that there is no toxicity in the range of water solubility for aquatic organisms (algae, daphnia and fish). Additionally, a bioaccumulation test is technically hardly feasible due to the highly insolubility of the substance and is not necessary due to the non-hazardous character of the substance.

In conclusion, docosanamide (CAS No. 3061-75-4) does not meet the B criterion.

Toxicity Assessment

Short term tests with species of 3 trophic levels are available for the structurally related substance amides, C16-C18 (even numbered) and based on this tests, the test substance can be regarded as acutely not harmful to aquatic organisms. Short term toxicity data of the substance towards fish, daphnia and algae give a NOEC greater than the water solubility of amides, C16-18 (even numbered). No toxicity could be observed in any test.

Additionally, long-term tests with the structurally related (Z)-docos-13-enamide (erucamide, CAS No. 112-84-5) were conducted. The available study report on long-term toxicity of erucamide to fish conducted according to OECD 215 demonstrates no effects up to the limit of the water solubility of the tested substance. The same applies for a long term Daphnia study according to OECD 202 for erucamide, detecting no effects up to the limit of the water solubility of the tested substance. Thus, docosanamide (CAS No. 3061-75-4) can be regarded as not harmful for aquatic organisms.

 

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, docosanamide (CAS No. 3061-75-4) does not meet the T criterion

 

Overall conclusion:

Docosanamide (CAS No. 3061-75-4) is no PBT or vPvB candidate substances