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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistence (P) Assessment

The substance 2,6-dibromo-4-cyanophenyl octanoate is not readily biodegradable according to OECD criteria (37% after 28 days; OECD 301B). The degradation half-life of 2,6-dibromo-4-cyanophenyl octanoate in two sediment water systems ranged from 4.2 to 8.5 hours (recalculated to 12 °C). The main degradation product in water and sediment was 3,5-dibromo-4-hydroxybenzonitrile. After 100 days 14CO2 formation accounted for 55.2 and 55.4% AR.

In soil, the substance attained 29.4 – 55.1% degradation (elevation of 14CO2) after 35 days and 19.4 °C, and the half-life of the test substance in soil was found to range from 0.14 – 0.62 days (0.28 – 1.25 days, recalculated to 12 °C)

The degradation of the transformation product and structural analogue [14C]-3,5-dibromo-4-hydroxybenzonitrile (CAS 1689-84-5) was investigated in natural water samples under aerobic conditions. Under the conditions of the test 3,5-dibromo-4-hydroxybenzonitrile remained stable (DT50 = >1000 days).

Based on the available data on the degradation product 3,5-dibromo-4-hydroxybenzonitrile, the target substance 2,6-dibromo-4-cyanophenyl octanoate is assessed as vP/P.

 

Bioaccumulation (B) assessment

The experimentally determined log Pow of 5.9 of 2,6-dibromo-4-cyanophenyl octanoate indicates a potential for bioaccumulation. However, a study on the bioconcentration in fish determined a BCF of 180 ± 40 (whole fish). Therefore, the substance does not meet the B criterion.

 

Toxicity (T) assessment

The substance is classified as H361d (“Suspected of damaging the unborn child”) and thus assessed as T.

Effect concentrations determined in chronic aquatic toxicity tests were < 0.01 mg/L.

 

 

Summary and overall conclusions on PBT or vPvB properties

 

Overall conclusion:

Based on the assessment described in the subsections above the substance is not PBT.

 

Justification:

According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to meet all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to meet all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII. Based on the relevant data provided and discussed, the substance is identified as vP and T, the substance is not identified as PBT or vPvB.