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PBT assessment

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PBT assessment: overall result

Reference
Name:
bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Ready Biodegradability test shows 54.1% degradation after 28 days, which does not fulfill the minimum criteria set out by the OECD method. This does however indicate that the material achieved >50% within 30 days, highlighting its propensity for biodegradation. An inherent biodegrability test shows 80.5% degradation after 28 days, therefore it is considered that the material is inherently biodegradable and as such not persistent in environmentally significant conditions.

 

While the Log Kow was shown to be 8.84, a bioaccumulation study has shown the mean BCF to be 9. The substance was shown not to significantly accumulate in fish tissue and was observed to be eliminated from the fish tissues over a 25 day depuration period. Based on this information the biological half-life of the test item is considered to be between 6 to 25 days.  

 

NOECs and EC10 for aquatic species were all > 0.01 mg/L. All genetic toxicity studies show no significant effects. All reproductive and developmental studies indicated that no relevant effects on either reproduction (fertility in the parent animals) or on the development of the offspring were observed, also NOEL of 1000mg/kg bw/d for 90 day repeat dose toxicity.

Given the available data, the material should not be considered Toxic.