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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:

1. Persistence assessment

Screening criteria - Remarks on ready biodegradability: Cumene hydroperoxide (CHP) proved not to be readily biodegradable according to OECD criteria

2. Bioaccumulation assessment

Screening criteria - Not B / vB based on Log Kow = 4.5: see studies described in CSR sections 1.3 (Partition coefficient n-octanol/water), 4.3.1 and 4.3.3 (The bioaccumulation potential was demonstrated to be low based on a BCF of 9. This is supported by a log Kow of 1.6.)

Conclusion of B / vB assessment Based on a low Log Kow, the substance is not considered to fulfill the B and vB criteria.

3. Toxicity assessment

Criteria based on Annex XIII of REACH - Not T based on the following criteria (see also underlying data basis in CSR section 7.1 (marine and freshwater] organisms (long-term toxicity and section 3 (Classification and labelling):

• EC10 / NOEC >= 0.01 mg/L for marine / freshwater organisms (long-term toxicity): Based on the available results on short-term toxicity to aquatic organisms, the lowest L(E) C50 was determined to be >1 mg/L.

• Substance is not classified as 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 or 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 (see also section "3 Classification and labelling"): Furthermore, the substance is not classified as carcinogenic (category 1a or 1b), mutagenic (category 1a or 1b), or toxic for reproduction (category 1a, 1b, or 2).

• No other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC) or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008 (see also section "3 Classification and labelling")

Conclusion of T assessment Based on these data, the substance is not considered to fulfill the T criterium.