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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:

Type of Data

PBT-Criterion

vPvB-Criterion

Value for Substance

Conclusion

Persistence

 

 

 

 

Ready Biodegradability test (screening)

Not readily biodegradable

Not readily biodegradable

Readily biodegradable

Not P

Biodegradability by Simulation Testing (definitive)

t1/2> 60 days in marine water, or

 

 

 

 

t1/2> 40 days in fresh or estuarine water, or

t1/2> 60 days in marine, fresh- or estuarine water, or

 

 

 

t1/2> 180 days in marine sediment, or

t1/2> 180 days in marine, fresh- or estuarine sediment, or

 

 

 

t1/2> 120 days in soil

t1/2> 180 days in soil

 

 

Abiotic degradation

 

 

 

 

Photodegradation

 

 

 

 

Bioaccumulation

 

 

 

 

Evidence of biomagnification (definitive)

BCF > 2000 L/kg

BCF > 5000 L/kg

BCF = 2.6 (experimental); BCF – 2.876 (modeled)

Not B

Octanol-water partition coefficient (screening)

Log Kow> 4.5

Log Kow> 4.5

Log Kow= 1.2 (experimental)

Not B

Toxicity

 

 

 

 

Aquatic toxicity

Long-term NOEC < 0.01 mg/L (definitive); or short-term EC50or LC50< 0.01 mg/L (definitive); or short-term EC50or LC50< 0.1 mg/L (screening)

 

Short term EC50= 320 mg/L (daphnids); ErC50= 320 mg/L (algae)

Not T

 

Classified as carcinogenic (category 1A or 1B) , mutagenic (category 1 or 1B) or toxic to reproduction (category 1A ,1B or 2), according to the CLP Regulation; or

 

Not CMR

Not T

 

Evidence of chronic toxicity, i.e., specific target organ toxicity after repeated exposure (STOT RE category 1 or 2), according to the CLP regulation.

 

No chronic toxicity

Not T

 

 

 

 

 

Detailed information regarding the PBT/vPvB determination is summarised in the table (above). The substance has been shown to be readily biodegradable and therefore is not persistent. The substance has a log Kow of 1.2, below the screening criterion of 4.5, above which a substance may be considered to be bioaccumulative and very bioaccumulative; the substance has a a measured aquatic bioaccumulation factor of 2.6 and a predicted BCF of 2.876, each substantially below both the definitive BCF thresholds of 2000 L/kg for bioaccumulative and 5000 L/kg for very bioaccumulative. This substance does not meet the screening criteria for aquatic toxicity, as the lowest short-term L(E)C50value of 320 mg/L is substantially above the definitive criterion of L(E)C50< 0.01 mg/L and the screening criterion of L(E)C50< 0.1 mg/L. The substance does not meet any of the criteria for mammalian toxicity in accordance with the CLP Regulation, i.e., carcinogenic (category 1A or 1B), mutagenic (category 1 or 1B), toxic for reproduction (category 1A, 1B or 2), or other evidence of chronic toxicity, i.e., specific target organ toxicity after repeated exposure (STOT RE category 1 or 2). Thus, the substance has been determined to be not persistent, not bioaccumulative and not toxic, and is considered to be not PBT and not vPvB.