Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

Sediment toxicity

Link to relevant study record(s)

Reference

Endpoint:

sediment toxicity: long-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

The available information shows that the substance is not classified with any hazards and substance properties gives rise to predict no effect concentrations which are undemanding andas such the chemical safety assessment should conclude safe use of the material.

With this in mind, long-term sediment testing on the substance is considered not necessary.

Additional information

According to Regulation (EC) No. 1907/2006, Annex X, Section 9.5.1 Column 2: Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on sediment organisms.  The substance is not classified for any hazards and hence a Chemical Safety Report is not required.  Hence there is currently no significant concern for long term effects in sediment organisms.

In addition to this primary argument (the absence of any hazard classification), key elements of the substance properties are examined to develop a secondary argument.

1) Biodegradation: While the substance is not readily biodegradable it is inherently biodegradable and hence not persistent in environmentally significant conditions. Ready Biodegradability test shows 54.1% degradation after 28 days, which does not fulfil the minimum criteria set out by the OECD method. This does however indicate T½ was achieved within 28 days, highlighting the materials propensity for biodegradation. An inherent biodegradability 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.

2) Partitioning: The substance shows a strong potential to bind to soils and hence can be predicted to bind to sediment.  The log Koc value form an OECD 121 study was >5.63.

3) Bioaccumulation: Bioaccumulation potential of the substance is however very low.   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 beeliminated 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.  

4) Aquatic toxicity: In toxicity tests, the substance displayed no observable effect on fish, daphnia, algae and microorganisms at the nominal concentration of 100mg/L. As such the material would not be considered toxic.  The above information gives rise to predicted no effect concentrations which are undemanding and as such the chemical safety assessmentshould conclude safe use of the material.  

With this biodegradation potential, low bioaccumulation and no environmental toxicity in mind, long-term sediment testing on the substance is considered not necessary.