Fatty acids, tall-oil, reaction products with acrylic acid

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.46 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.15 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.046 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.015 mg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

9.8 g/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

765.3 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

76.5 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:

152.3 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

PNECsediment and PNECsoil: No data are available for the toxicity of Diacid 1550 for sediment organisms and terrestrial organisms. The toxicity is derived from equilibrium partitioning using the organic carbon partitioning coefficient Koc for Diacid 1550. However, the Koc has not been determined but predicted. It is not certain whether this prediction is correct, as the substance is an acid but under environmental conditions it will be in its ionic form. However, for the risk characterisation the same Koc is used both for the PNEC derivation and for the estimation of the PEC, so in the end it does not affect the risk characterisation ratio. However, for comparison of PNECsediment and PNECsoil to those for other substances, the limitations due to the Koc should be taken into account.

PNECoral (secondary poisoning) can be derived from the repeated dose toxicity test that was combined with the reprotox screening test (see IUCLID 7.5.1 and 7.5.8). The effects relevant for wildlife populations are related to mortality, reproduction or growth. In this study the parents were exposed for 28 - 40 days starting two weeks prior to mating. Females and offspring were exposed until termination after day 4 of lactation. Effects on clinical chemistry of the parent animals were observed at lower concentrations but no effects were observed on the reproduction and the development of the 4d-old offspring. Therefore the relevant NOAEL was 1324 mg/kg bw/d. NOEC(oral) = NOAEL(rat) * CONV. CONV for rat (> 6 weeks) is 20 (Guidance R.10) so NOEC(oral) = 1324 * 20 = 26.5 g/kg food. The females were exposed during 40 days. Using the Assessment factor fo 28 days, the PNEC(oral) is derived by NOEC(oral)/300 = 88.3 mg/kg food.

However, the risk for predators on secondary poisoning is considered of no concern, since the substance is not expected to accumulate and it is not classified with specified hazard categories. Therefore no PNEC was given in the relevant fields.

Conclusion on classification

Acute (short-term) aquatic hazard

Acute toxicity data for fish, crustaceae and algae are > 1mg/l. Therefore the substance needs no classification with Category Acute 1 according to CLP criteria.

 

Long-term aquatic hazard

Adequate chronic toxicity data is available for fish, invertebrates and algae. All NOEC values found were > 1 mg/L and the substance is readily biodegradable. Therefore the substance needs no classification for Category Chronic 1, 2 or 3 according to CLP criteria.

Safety net classification

The safety net classification does not apply. The substance is water soluble under the conditions of the toxicity studies, the substance is readily degradable and information on bioaccumulation suggests a low bioaccumulation potential. Therefore the substance needs no classification as Chronic Category 4

 

Conclusion

The substance does not need to be classified for any environmental hazard.