Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.194 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.18 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.019 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Reliable and GLP-conform acute toxicity studies of m-toluic acid are available for algae, daphnids, and fish. Algae appear to be most sensitive with a 72-h EC50 of 18 mg/L. Thus, all effect concentrations are well above the classification cut-off value for acute (short-term) aquatic hazard category 1. Therefore, m-toluic acid does not meet classification criteria as short-term hazard to the aquatic environment under Regulation (EC) No 1272/2008 and its subsequent adaptations.

 

Regarding chronic toxicity, reliable and GLP-conform studies are available for algae and daphnids; the lowest effect concentration is the 21-d NOEC of 9.7 mg/L for the reproduction of daphnids. According to the QSAR-based outcome of the model ECOSAR v.2.0, m-toluic acid has a very low potential for chronic toxicity to freshwater and saltwater fish with chronic values (ChV = 10^([log (LOEC x NOEC)]/2)) for freshwater and saltwater fish of 47.9 mg/L and 82.9 mg/L, respectively. Thus, effect concentrations and QSAR-based estimates are well above the classification cut-off values for long-term aquatic hazard category 1 -3. Criteria for the "Safety net" classification in Category Chronic 4 are also not met. m-Toluic acid is rapidly biodegradable and the log Kow is well below 4. Therefore, m-toluic acid does not meet classification criteria as long-term hazard to the aquatic environment under Regulation (EC) No 1272/2008.