Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.65 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.065 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
72.2 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
7.22 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
14.4 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

A comparison of existing and acute chronic data across (spanning several classes: dialkyl peroxides, diacyl peroxides, peroxymonocarbonates, hydroperoxides, ketone peroxides, peroxydicarbonates, peroxyketals and peroxyesters) was made for several organic peroxides belonging to the consortium, and this is summarised in position paper attached in IUCLID Section 13.

 

The results were as follows:

Acute to chronic ratios, based on comparison of acute data with EC10 values

Algae: 3.2

Daphnia: 5.3

Fish: 1.9

 

Based on the acute data, a species sensitivity analysis indicated that algae are almost always the most sensitive species or as sensitive for short term studies to organic peroxides.

As an outcome of this analysis, the following was concluded:

Fish are generally the least sensitive species, thus where fish data are absent, hazard asssessment can be performed based on algae and Daphnia data only.

Conclusion on classification

Acute classification

The existing acute data for algae and Daphnia show a NOEC value > maximum water solubility limit.100 mg/L (loading)]. Fish are assumed to be the least sensitive organism based on the conclusions of the attached position paper "OP Consortium PP_Acute to Chronic Ratio.pdf" As all effect values are above 1 mg/L,there is no acute classification for this substance

Chronic classification

Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide is not readily biodegradable, and the measured log Kow is 7.34. The only chronic data available are for Daphnia and algae where the NOEC values are greater than maximum water solubility. When chronic data for less than 3 trophic levels are available the classification is assessed using both the existing chronic and acute data, and the most stringent outcome is chosen.

Based on chronic data: (Daphnia and algae, NOEC > maximum water solubility): No classification

Based on acute data (NOECs > maximum water solubility): No classification

Category chronic 4 evaluation- Substance is poorly water soluble, with no acute toxicity recorded up to the water solubility, is not rapidly degradable and the log Kow > 4. However the chronic toxicity NOEC > water solubility and 1 mg/L , thus it does not fit into this category

Most stringent outcome:None

Overall classification: None