OligoActiv EDDHA-Mn

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

41 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.41 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

4.1 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

41 µg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

45 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.22 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

22 µg/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:

20 µg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Derivation of PNECs

The PNECs for the different compartments are calculated either by application of an assessment factor (PNEC freshwater, PNEC marine water, PNEC intermittent release and PNEC stp) or by using the equilibrium assumption method (PNEC sediment-freshwater, PNEC sediment-marine-water and PNEC soil). The PNEC air is not considered as relevant based on the chemical structure and intrinsic properties of the registered substance. Secondary exposure of mammals and birds is not expected, and since no adequate bird or mammalian data are available, the PNECsecondary poisoning is omitted. The utilized procedures are described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

Conclusion on classification

There is no data available for the target substance on toxicity towards aquatic organisms and microorganisms. However, there is data available for the source substances (manganese salts and Fe(Na)EDDHA). With regard to the data for manganese the hazard values were converted to the registered substance under consideration of the maximum percentage of manganese included in the substance. This data is used within the concept of a weight-of-evidence approach to assess the toxicity of the target substance.

According to the LC/EC50 data derived from OECD guideline studies with the source substance Fe(Na)EDDHA, representing the organic part of the target substance Mn(Na₂)EDDHA, it can be concluded that no toxicity towards aquatic organisms is triggered by this compound.
Taking into account the lowest acute LC/EC50 value found in literature for manganese compounds including MnSO₄and MnCl₂, converted to the manganese moiety in the target substance an ERV of = 41.33 mg/L for Selenastrum capricornutum has been derived. Applying the criteria for classification of soluble metal compounds specified in the ‘Guidance on the Application of the CLP Criteria’ (version 5.0 – July 2017), Annex IV, classification for acute environmental toxicity is not needed if the ERV > 1 mg/L. No chronic data has been provided in the dossier as this is not a requirement under Annex VIII to REACH Regulation. (In absence of relevant chronic toxicity data, and unless there is evidence of both rapid environmental transformation and evidence of no bioaccumulation, readily soluble metal compounds are classified as Category Chronic 3 if the acute ERV > 10 mg/L and ≤ 100 mg/L.) Nonetheless reliable chronic data is available according to the disseminated REACH registration dossiers of MnSO₄and MnCl₂. The lowest chronic value was obtained in the brook trout study (Davies & Brinkman 1998*) with MnSO₄ of 0.55 mg Mn/L. After correction to the Mn moiety in the target substance a chronic ERV of 7.3 mg/L can be derived. In cases where both the acute and chronic ERV are greater than 1 mg/L there is no need to classify for either acute or chronic effects according to Regulation (EC) No 1272/2008.

 

*Davies, P.H. and S.F. Brinkman. 1998. Toxicity of manganese to early-life stage and fry of brook trout (Salvelinus fontinalis) and rainbow trout (Oncrhynchus mykiss) in water hardnesses of 30 and 150 mg/L. Federal Aid in Fish and Wildlife Restoration Job Progress Report, Colorado Division of Wildlife, Fish Research Section.Fort Collins, CO, USA