Benzene, bis(1-methylethyl)-, sulfonated, sodium salts

PBT assessment

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 E_rC₅₀ 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.