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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
boundary composition of the substance
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
boundary composition of the substance
Reference substance:
boundary composition of the substance
Reference substance:
boundary composition of the substance
Reference substance:
boundary composition of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence: The results from the ready biodegradability closed bottle test (screening criterion) indicated 1.4% biodegradation. 

 

No definitive determination on persistence can be made based on available information. However, in the absence of a definitive determination, the substance may be described as potentially “persistent” (“P”) and potentially “very persistent” (“vP”), based on the screening criteria for ready biodegradability.

 

Bioaccumulation: The experimentally-determined octanol-water partitioning coefficient for the substance show that the value meets the screening criterion (i.e.,log Kow ≤ 4.5) to determine that the substance is “not bioaccumulative” (“not B”) and “not very bioaccumulative” (“not vB”). 

 

Toxicity: A determination regarding the mammalian toxicity of the substance indicates that the substance is not toxic. With respect to mammalian toxicity, the substance has not been classified as “carcinogenic, mutagenic or toxic for reproductive toxicant” (CMR) and has not been classified as “STOT RE”, with respect to chronic exposures; these are definitive determinations of “not T” with respect to mammalian toxicity.

 

The results of the short-term aquatic toxicity tests indicate that that the substance is presumably “not toxic” (“not T”) when compared to the screening criteria for short-term aquatic toxicity.  The LC50 for fish was reported at > 100 mg/L, the EC50 for daphnids was reported as > 100 mg/L, and the ErC50for algae was reported as > 100 mg/L. Therefore, all acute toxicity L(E)C50 values were four orders of magnitude above the definitive aquatic toxicity criterion of L(E)C50< 0.01 mg/L, and three orders of magnitude above the aquatic toxicity screening criterion of L(E)C50< 0.1 mg/L.The substance may be considered to be presumably "not T" for both acute and chronic exposures. 

 

Conclusions: Any determination based on screening criteria requires that “each of the three properties persistency, bioaccumulation and toxicity need to be considered in conjunction” (Chapter R.11, “PBT Assessment”,Guidance on information requirements and chemical safety assessment, ECHA, 2014, Section R.11.). Therefore the substance does not fulfil the PBT and vPvB criteria.