Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.6 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
8.75 µg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10.41 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.041 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
4.05 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
5 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

The substance exhibits surface active properties (non-ionic) and thus meets the criterion for substances difficult to test. The surface activity has been experimentally verified by determination of surface tension (26.6 mN/m, solution 1 g/L). It is expected that the substance can form emulsions in aquatic testing making assessment of bioavailability difficult to ascertain. The critical micelle concentration has been determined to 7.55 µg/mL at 20°C. One of the main difficulty with testing the substance was the maintenance of exposure concentrations. Generally, concentrations were recovered in applications solutions but deviated more than 80% of nominal values in test solutions either in the course of experiment or at the moment of medium renewal/end of experiment. Thus, effect concentrations were expressed as geometric means.

-Short-term toxicity

Fish Acute (2004): 96h-LC50 = 1.02 mg/L (95% CL: 0.48 -2.2 mg/L) based on meas. geom.

Fish Acute (2003): 96h-LC50 = 1.61 mg/L (95% CL: 1.32 -3.01 mg/L) based on meas. geom.

Daphnia Acute (2004): 48h-EC50 = 1.1 mg/L (95%CL: N/A) based on meas. geom.

Daphnia Acute (2003): 48h-EC50 = 0.875 mg/L (95% CL: 0.5 -1.40 mg/L) based on meas. geom.

Algae (2003): 72h-ErC50 = 1.11 mg/L (95% CL: 0.821 -1.64 mg/L) based on meas. geom. 72h-NOECr = 0.5 mg/L

Algae (2004): 72h-ErC50 = 2.1 mg/L (95% CL: 0.34 -4.9 mg/L) based on meas. geom.; 72h-NOECr = 0.62 mg/L

-Long term toxicity

Fish Chronic (2011): 30d-NOEC = 0.086 mg/L (no significant difference with vehicle control) based on meas.

TWA Daphnia Chronic (2004): 21d-NOEC = 0.036 mg/L based on meas. TWA

-Evidence of rapid degradation in aquatic system is provided in the dataset

OECD Guideline 301B: %Biodeg. = 88% (Day 28) based on CO2 evolution. The 10 -day window started on Day 5 and the test substance attained 69% of biodegradation on Day 15.

-Bioaccumulation

No fish bioconcentration factor is available. Log kow for main constituent equal to 3.757 (est.).

CLP Classification proposal

It is proposed to compare CHIMEXANE dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute Cat 1 Reasoning: lowest E(L)C50 below 1 mg/L but > 0.1 mg/L. M-Factor of 1.

Chronic Cat 2 Reasoning: readily biodegradable substance, lowest toxicity value between 0.01 and 0.1 mg/L. M-Factor not applicable.

DSD Classification proposal

N; R50/53 Reasoning: lowest E(L)C50 below 1 mg/L, readily biodegradable but log Kow of main constituent > 3.0.