Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.002 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
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:
0.076 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

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

Additional information

The acute toxicity study in fish produced no adverse results, with LC50 and NOEC values presented as limits at > 100% v/v saturated solution. The acute toxicity study in Daphnia produced no adverse results, with LC50 and NOEC values presented as limits at > 100% v/v saturated solution. The algae study also produced no adverse results, with EC50 and NOEC values > 100% v/v saturated solution.

 

It should be noted that the substance did not demonstrate any toxic effects at its limit of solubility in water. As such, the values presented for PNECs are as derived using guidance document “R10 - Characterisation of dose [concentration] - response for environment”. As the guidance for deriving the PNEC does not provide assessment factors for substances with no effects at the limit of solubility, the assessment factors as proposed have been applied. 

The respiration inhibition rates of microorganisms in sewage when exposed to TIS-M were assessed according to EU Method C.11. A positive control substance 3,5-Dichlorophenol was also used. The 3-hour EC20, EC50 and EC80 were determined to be higher than 1000 mg/L based on measured inhibition rates. The NOEC was determined to be 100 mg/L.

Conclusion on classification

The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols.

Based on its rapid hydrolysis at pH 4, 7 and 9, it can be concluded that TIS-M is not expected to be persistent within the environment therefore the above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).