Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1 588 000 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
158 800 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
316 400 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Calculation of PNEC water was based on results obtained in short-term studies on fish, daphnia and algae, namely L(E)C50 > 1000 mg/l as loading rate. These results indicate the lack of acute toxicity for the three trophic levels up to concentration of 1000 mg/l as loading rate. The effective concentrations measured at the end of the test were in the range 83 - 92 mg/l. According to ECHA guidance R7b for slightly soluble substance for which no effect at concentration below 100 mg/l was observed, the PNEC should be calculated on limit value of solubility in the medium. For this substance the limit of solubility in the medium is expected to be similar to the solubility of the substance in water (i.e. 96.3 mg/l) approximated to 100 mg/l. LC50 /EC50>100 mg/l has been chosen as representative value for the PNEC calculation since no effect has been observed up to the measured concentration of 83 - 92 mg/l.

Conclusion on classification

According to the CLP Regulation (EC n.1272/2008), the threshold of classification of a substance for acute aquatic toxicity is 1 mg/l. This limit is compared with LC50 (96h) for fish, EC50 (48 h) for daphnia and EC50 (72 - 96 h) for algae or aquatic plants.

An experimental value of LC50 96h fish > 1000 mg/l loading rate, corresponding to 83 mg/l measured concentration was obtained for this substance.

A study to assess the short-term toxicity to Daphnia Magna was performed and the result of the test was EC50 48h Daphnia Magna > 1000 mg/l loading rate, corresponding to 92 mg/l measured concentration.

Toxicity on algae was assessed in 72 -hour test always on this substance. EC50 for algal growth rate was identified as higher than 1000 mg/l loading rate, corresponding to 92 mg/l measured concentration.

No chronic toxicity data is available from long-term studies. In case of lack of chronic data, the potential for chronic toxicity is identified by appropriate combinations of acute toxicity data and lack of biodegradability. The threshold of classification is 100 mg/l.

The multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite" is not toxic for aquatic environment after short-term exposure so no classification for both acute and chronic aquatic toxicity is applied according to the CLP Regulation (EC n.1272/2008). 

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