Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.11 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.001 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.011 µg/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:

54 µg/kg sediment dw

Extrapolation method:

sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

5.4 µg/kg sediment dw

Extrapolation method:

sensitivity distribution

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

64.26 µg/kg soil dw

Extrapolation method:

sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

8 mg/kg food

Assessment factor:

300

Additional information

The test substance HiTEC7134 is highly toxic to aquatic organisms, and is not readily biodegradable. Low L(E)C50 values were reported for the three species tested: fish, daphnia and algae, the invertebrate Daphnia magna being the most sensitive species. The 48-hour EC50 for daphnia was reported as 0.11 mg/L, and this value was used for the determination of the PNECs aqua. See above for the detailed description.

The calculation of the PNEC_stpwas performed using the NOEC from an activated sludge respiration inhibition study (NOEC = 100 mg/L).

The equilibrium partitioning method (EPM) was applied for the calculation of PNECs for sediment (freshwater and marine water) and soil, using an extrapolation from the PNECaqua. Note that HiTEC7134 is a highly lipophilic substance, with a Log kow between 6.4 - 7.6, and the EPM may underestimate toxicity for compounds with a Log Kow above 6. The ECHA guidance advises to increase the PECsed/PNECsed ratio by a factor of 10, in order to take uptake via ingestion of sediment into account (ECHA guidance R.10 page 33). The same principle accounts for the soil compartment (page 40).

To derive the safe level for oral exposure, the NOAEL for rats was used since the dossier does not contain toxicity data with birds (requirement only for Annex X substances). In this study an NOAEL of 15 mg/kg body weight/day was reported, from a repeated-dose toxicity study using the oral route of exposure.

There is also a newer reproduction/development toxicity study (Reproduction/developmental toxicity screening test of HiTEC 7134 in rats by oral gavage, Notox B.V.; project no. 496483; 2012) in which extra blood work was collected so it was more like the combined sub-acute oral/repro study. Based on the newer study, the new NOAEL is 120 mg/kg body weight/day. This value of NOAEL was used to calculate the PNEC_oralas described earlier.

For further details of PNEC derivation see attached spread sheet with calculations.

Conclusion on classification

HiTEC 7134 was highly toxic to all three species tested. The lowest L(E)C 50 value of 0.11 mg/L resulted from an acute toxicity study with Daphnia magna. The substance is not readily biodegradable, only 27% biodegradation was achieved after 28 days of exposure. Based on this information, HiTEC7134 Performance additive shall be classified for acute aquatic hazard Cat. 1 "H400: Very toxic to aquatic life" and also category 1 for chronic toxicity "H410: Very toxic to aquatic life with long lasting effects" in accordance with the CLP Reg (EC) 1272/2008.