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PBT assessment

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PBT assessment: overall result

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

Substances are considered as PBT or vPvB substances when they fulfil the criteria for all three (or two) inherent properties P, B and T or vP and vB, respectively.

The log POW of the test item Ukanol FR 70 was estimated to be in the range from < 0.3 to 3.324.

Therefore based on the highest log Kow of 3.324 the B/vB criterion is not fullfilled.

In addition the T criterion is not fullfilled.

Following ecotoxicological data were estimated for the substance:

Short-term toxicity to fish:

96h NOEC ≥ 0.85 mg/L

96h LC50 > 0.85 mg/L

Short-term toxicity to aquatic invertebrates:

24h-NOEC ≥ 7.0 mg/L

48h-NOEC ≥ 7.0 mg/L

24h-EC50i > 7.0 mg/L

48h-EC50i > 7.0 mg/L

Toxicity to aquatic algae:

Endpoint        NOEC       LOEC       EC50

Growth Rate        > 11 mg/L       > 11 mg/L       > 11 mg/L

AUC        > 11 mg/L       > 11 mg/L       > 11 mg/L

Yield        > 11 mg/L       > 11 mg/L       > 11 mg/L

The substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 or carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC.

Based on available data there is no evidence of chronic toxicity, the substance does not meet the criteria for classification as STOT RE 1, or STOT RE 2 according to the CLP Regulation or T, R48, or Xn, R48 according to Directive 67/548/EEC.

In conclusion, in accordance with Annex XIII of the REACH regulation, the substance does not satisfy all the 3 mentioned criteria of P, B and T and so is not a PBT (including vPvB) substance.