Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

No relevant effects

Key value for chemical safety assessment

Additional information

This endpoint is covered by the category approach for soluble iron salts (please see the section on physical and chemical properties for the category justification/report format). 

Testing for this endpoint has been waived in accordance with column 2 and Annex XI, part 1 and 2, restrictions.

Information from Literature Searches and earlier Assessment Approaches

The literature reviews of Vangheluwe & Versonnen (2004), Johnson et al. (2007) and OECD (2007) revealed some data. The results of the studies, selected as “reliable” by the respective authors are listed in the following tables. Nonetheless the experiments must be rated “not reliable” (Klimisch 3) according to the Klimisch et al. (1997) scale due to methodological objections against testing of aquatic organisms as concluded in the beginning of this chapter (section „Ecotoxicological information“). True, intrinsic toxicity of iron kations in aerobic aquatic test organisms cannot be determined in studies when the solubility of the dissolved ferric kation (as the ferrous form will readily be oxidized to ferric species) is exceeded. None of the experiments found effects at such low levels (depend on pH, section “water solubility”). Notwithstanding the methodological objections formally expressed in the waiving argument for the standard aquatic test organisms, the following data are mentioned for completeness.

Freshwater species:

Table: Data from the EURAS critical review (Vangheluwe & Versonnen 2004, table 5, p 21)

Test
substance

Test organism

Test medium

Test
conditions

Nominal / Measured

Duration

Endpoints

EC50 [mg/L]

Reference

Reliability

Fe3+

Lemna minor

deionized water

pH: 7.5;

T: 27

N

4 days

growth

3.7

Wang 1986

R3

N: Nominal concentration

R3: Not reliable according to the authors (set out in chapter 3.2 of their publication)

T: Temperature [°C]

Table: Acute aquatic toxicity data on Macrophyta according to Johnson et al. (2007, Table 2.6, p 22)

Scientific name

Common name

Endpoint

Effect

Test duration [days]

Concentration

[mg /L]

Exposure

Toxicant analysis

Comments (Author's Reliability)

Reference

Lemna minor

Lesser duckweed

EC50

Growth

4

3.7

s

n

As FeCl3; pH 7.5 (R3)

Wang 1968

Spriodela polyrrhiza

Greater duckweed

NOEC

Growth

7

16

s

n

As FeCl3; pH 7.5 (R3)

Sinha et al 1994

Exposure: s = static; ss = semi-static; f = flow-through

Toxicant analysis: y = measured; n = not measured.

R3: Not reliable according to the authors (set out in Annex 1, p 56 of their publication)

Table: Long-term aquatic toxicity data on Macrophyta from the OECD (2007) assessment (table 30, p 71)

Test substance

Test organism

Test duration

Effect

Endpoint [mg Fe/L]

Reference

Author’s Reliability

FeCl3

Spirodela polyrrhiza

14 d

Growth effects at pH 7.5

<0.56 (NOEC, m)

Sinha et al. 1994

R2

0.56 (LOEC, m)

m = measured total iron

R2 = Rating by the authors (OECD 2007) referring to the Klimisch et al. (1997) scale, corrected to Klimisch 3 “not reliable” as discussed above.

Saltwater species:

No relevant data were reported by Vangheluwe & Versonnen (2004), Johnson et al. (2007) and OECD (2007).

  • Johnson I, Sorokin N, Atkinson C, Rule K, Hope S-J (2007). Proposed EQS for Water Framework Directive Annex VIII substances: iron (total dissolved). ISBN: 978-1-84432-660-0. Science Report: SC040038/SR9. SNIFFER Report: WFD52(ix). Product Code SCHO0407BLWB-E-E. Self-published by Environment Agency, Almondsbury, Bristol BS32 4UD, U.K. 65 p.
  • Klimisch H-J, Andreae M, Tillmann U (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharm 25:1-7.
  • OECD Organisation for Economic Co-operation and Development (2007). SIDS Initial Assessment Report for SIAM 24. Chemical Category: Iron Salts. Self-published, Paris, France, 17-20 April. 138 p.
  • Sinha S, Rai UN, Chandra P (1994). Accumulation and toxicity of iron and manganese in Spirodela polyrrhiza (L.) schieiden. Bulletin of Environmental Contamination and Toxicology. 53(4):610–7.
  • Vangheluwe M, Versonnen B (2004). Critical review on acute and chronic aquatic ecotoxicity data to be used for classification purposes of iron sulfate. Commissioned by ARCELOR SA, CEFIC, EUROFER, Rio Tinto plc. Final report - 25 August 2004. Prepared by EURAS, Rijvisschestraat 118, box 3. B-9052 Gent, Belgium. 76 p.
  • Wang W. 1986. Toxicity tests of aquatic pollutants by using common duckweed. DOI 10.1016/0143-148X(86)90028-5 Environmental Pollution Series B 11(1):1-14.