Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.79 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Additional information

PNECs were derived from the study with the most sensitive species available for each compartment/endpoint.

Conclusion on classification

Studies investigating potential environmental effects have been undertaken on tetrahydromethylphthalic anhydride (MTHPA). This is a structural analogue of 3 -MTHPA D4 in which the methyl substitution is not defined or fixed in a specific position on the carbon cyclic structure, as opposed to 3 -MTHPA D4 where the methyl substitution is fixed at the 3C position. 3 -MTHPA D4 is regarded as a specific isomer of MTHPA.

Acute toxicity:

Based on the results obtained in aquatic toxicity studies, MTHPA was not classified and labelled according to Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).

Chronic toxicity:

Based on the results obtained in long-term aquatic toxicity studies, MTHPA was not classified and labelled according to Directive 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).

Overview of Results used for Classification and Labelling:

Fish, short-term, freshwater: LC50 (96 h) > 100 mg/L (Anonymous, 1997)

Fish, long-term, freshwater: NOEC(14 d) = 100 mg/L (Anonymous, 1997)

Daphnia magna, short-term, freshwater: LC50 (48 h) = 130 mg/L (Anonymous, 1997)

Daphnia magna, long-term, freshwater: NOEC (21d) = 20 mg/L ( Vértesi A, 2010)

Algae, freshwater: LC50 (72 h) = 68 mg/L (Anonymous, 1997)