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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:

For the purposes of the PBT evaluation, both the registered substance (EC 272-486-4) and TPP (EC 310-154-3) are evaluated. TPP has active registration and CLH dossiers; the bioaccumulation study with TPP is summarized in section 4 of this CSR.

EC 272-486-4

The registered substance is potentially persistent and meets the ‘P’ criteria. However, it does not meet the criteria for bioaccumulation or toxicity and is, therefore, not a PBT or vPvB substance.

TPP (Tetrapropenyl phenol, EC 310-154-3)

TPP is potentially persistent (25% degradation after 28 days in an OECD 301B) and meets the T criteria as it is classified as a Category 1B reproductive hazard. However, TPP does not meet the bioaccumulation criteria based on a well-conducted OECD 305 guideline study. Therefore, TPP is not a PBT or vPvB substance.

Persistence Assessment

Alkyl phenate sulfides such as EC 272-486-4 do not demonstrate the potential to readily biodegrade. The nominal degradation observed in CO2 Evolution studies is 4.7 – 13.4% based on experimental data. Because these substances do not meet the criteria in screening tests for ready biodegradation, the substance exhibits the potential to persist in the environment.

Bioaccumulation Assessment

As demonstrated in section 4.3.3, neither EC 272-486-4 or the residual constituent, TPP, exhibit the potential to bioaccumulate. The registered substance is assigned a BCF value of 2.2 based on a SPMD study that is supported by a weight of evidence assessment. TPP is assigned a BCF value of 823 based on a well conducted OECD 305 guideline study.

Toxicity Assessment

EC 272-486-4 is classified a Category 1B reproductive hazard based on the presence of TPP. The reproductive toxicity is evaluated in section 5.9 of this CSR. In summary, alkyl phenate sulfides such as EC 272-486-4 are not reproductive hazards based on an OECD 415 one-generation reproductive toxicity study conducted with a synthesized alkyl phenate sulfide depleted of TPP (to < 0.2%).

The observations in the OECD 416 Two-Generation Reproductive Toxicity study with EC 272-234-3 resulted in decreased female fertility, prenatal toxicity, decreased maternal body weight gain during gestation, and decreased maternal food consumption during lactation at 1000 mg/kg/day, the highest dose tested. These findings are consistent with the toxicity observed in tests with TPP, including in an OECD 416 study. In addition, when the residual amount of TPP present in EC 272-234-3 is used to calculate a dose of TPP delivered in the EC 272-234-3 study, the potency of observed effects is comparable to the dose of TPP that caused these effects the TPP study; this further supports that TPP is the source of the reproductive toxicity. 

    

Conclusions and Summary:

The information available indicates that alkylphenate sulfides and EC 272-486-4 are not PBT or vPvB substances. It does not meet the ‘B’ (or vB) criterion and the substance itself does not meet the T criterion. Regarding the residual constituent, TPP, the PBT or vPvB criteria are also not met. TPP meets the ‘T’ criteria and potentially the ‘P’ criteria but does not meet the ‘B’ criteria.