Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 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:
3.6 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.36 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.14 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Short-term test results are available for the toxicity of [3-(2,3-epoxypropoxy)propyl]trimethoxysilane to freshwater fish (Brachydanio rerio), invertebrates (Daphnia magna) and algae (Pseudokirchnerella subcapitata). The relevant short-term values are:

Fish:LC50 (96 h): 55 - 276 mg/l

Daphnia:EC50 (48 h): 324 mg/l

Algae:EC50 (7 d): 119 mg/l

A long-term toxicity to daphnia study is available giving a NOEC of ≥100 mg/l. A NOEC of <50 mg/l (EC10 40 mg/l) was determined in the key algal study; however, this result is not used for PNEC derivation because the duration of this study was longer than standard, being 7 days. A 96 h NOEC of 130 mg/l and a 72 h EC10 of 190 mg/l (based on growth rate) were determined in the two supporting studies. However, no long-term data are available for the trophic level (fish) which was most sensitive in the short-term studies.Therefore, an assessment factor of 100 is applied to the lowest NOEC from a long-term study, which is100 mg/l from the invertebrates study.

Conclusion on classification

It is proposed that [3-(2,3-epoxypropoxy)propyl]trimethoxysilaneshould not be classified for effects on the environment. This is on the basis of LC50 or EC50 values from short-term tests for fish, daphnia and algae of 55 to 276 mg/l, 324 mg/l and 119 mg/l respectively, an EC10 for algae of 40 mg/l and a long-term NOEC for invertebrates of ≥100 mg/l.