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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:

The table below provides an overview of the criteria as reported in Annex XIII of the REACH Regulation and a justification for the SDIBP whether or not to fulfill the criteria.

PBT criteria

vPvB criteria

SDIBP

Evaluation

Persistence

T1/2 marine water > 60 days, or

T1/2 fresh or estuarine water > 40 days, or

T1/2 marine sediment >180 days, or

T1/2 fresh or estuarine sediment > 120 days, or

T1/2 soil > 120 days

T1/2 marine, fresh or estuarine water > 60 days, or

T1/2 marine, fresh or estuarine sediment > 180 days, or

T1/2 soil > 180 days

Inherently biodegradable

Hydrolytically stable

Criteria is fulfilled

Bioaccumulation

Bioconcentration factor (BCF) > 2000

Bioconcentration factor (BCF) > 5000

Log Kow = -3.11

BCF< 2.3L/kg

Criteria not fulfilled

Toxicity

Long-term NOEC marine or fresh water organisms is < 0.01 mg/L, or

Substance is classified as carcinogenic (cat 1 or 2), mutagenic (cat 1 or 2), or toxic for reproduction (cat 1, 2 or 3), or

Other evidence of chronic toxicity as identified by the classifications; T, R48, or Xn, R48 according to Directive 67/548/EEC4

 

Available short-term aquatic toxicity values show a lowest EC50 of 100 mg/L (Daphnia)

Not classified as CMR substance

No other evidence of chronic toxicity as identified by classification

Criteria not fulfilled

An evaluation of the inherent properties of SDIBP is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.

The available evidence on degradation is sufficient for an assessment based on the Annex XIII criteria for persistence (P and vP). As the substance is concluded not to be readily biodegradable (inherently; 36% biodegradation in 56days) and hydrolytically stable, the screening criteria for persistence are fulfilled. Based on available evidence, it is thus concluded that the substance is potentially P or vP.

The available evidence on bioaccumulation potential (Log Kow = -3.11) indicates that the Annex XIII criteria for bioaccumulation potential (B and vB) are not met. The bioaccumulation study performed with a hydrotrope confirms this (BCF< 2.3L/kg). Hence, SDIPB is considered to be not B.

The acute aquatic toxicity to SDIBP is very low (48-h EC50to D. magna> 100 mg/L; 72-h ErC50 to P. subcapitata> 100 mg/L; 96h-LC50 to O. mykiss > 100 mg/L) and the chronic toxicity to algae is greater than 1 mg/L. SDIPB is also considered not to be a CMR. Hence, the T criterion is not met.

In conclusion, SDIBP should not be considered as a PBT/vPvB substance based on the assessment. No further testing is required.