Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.025 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.294 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.029 mg/kg sediment dw
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:
0.237 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The read across to BPFDGE from the structural analog BADGE (CAS#1675-45-3, EC#216-823-5) is appropriate as there are many study results, including phys/chem, ecotoxicology and mammalian toxicology that indicate similar characteristics. The structure of the diglycidyl ethers differ only at the center carbon where BADGE has two methyl groups while the BPFDGE has no branched alkyl groups. One long term test with Daphnia magna and an activated sludge inhibition test were conducted with BADGE and read across to BPFDGE.

 

In the chronic daphnia study the NOEL for the test material was 0.3 mg/L. The freshwater PNEC is derived from this study with an assessment factor 100 to give a value of 0.003 mg/L for freshwater organisms. Similarly the marine PNEC is 0.0003 mg/L with an assessment factor of 1000 derived from this study. 

 

The STP PNEC is derived from the microorganism study with BADGE. The NOEC value of 100 mg/L was selected as the key parameter for this endpoint and with an assessment factor of 10 gives an STP PNEC of 10 mg/L.

 

The PNEC for sediments and soil were calculated using the freshwater PNEC and equipartition method derived from EUSES 2.1 and ECETOC TRA.

 

For acute toxicity there are multiple studies for each endpoint that have been performed with the substance described as “formaldehyde, oligomeric reaction products with 1-chloro-2,3-epoxypropane and phenol (CAS# 9003-36-5), Depending of the conditions of the reaction, the formation products can results oligomers up to the polymer molecular weight range and structure.

 

The products tested for acute toxicity in daphnia, algae and fish are a range of these oligomers, EPIKOTE 862 on the low molecular weight end and the TK 12225/D, DEN 438 and EPIKOTE 155 on the higher end of molecular weights. GPC of these substances are virtually identical with only slight indications to molecular weight range. The EPIKOTE 862 studies had high loading rates and a long mixing time, which had the potential to selectively extract more soluble impurities that could be more toxic. The study with DEN 438 and TK 12225/D both used a solvent to create the test solutions, which created a cloudy suspension not necessarily representative of the toxic action of the substance. Some of the suspension at higher loading rate was observed to precipitate out. The EPIKOTE 155 study used a high loading rate (1000 mg/L) generate test solutions. The actual concentrations were not measured as the amount soluble in water would be below the level of detection. Even at this high loading rate there was insufficient test material solved in the test solution to exhibit any toxicity.

 

To reconcile these studies and develop a dose descriptor for the endpoints, the appropriate studies with the products EPIKOTE 862, DEN 438 and TK 12225/D have been averaged in a weight of evidence approach to and the EPIKOTE 155 studies are used as a supporting studies.

Conclusion on classification