Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.064 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.32 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
500
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:
6.38 mg/kg sediment dw
Assessment factor:
500
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.64 mg/kg sediment dw
Assessment factor:
5 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
6.36 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Aquatic

A standard acute toxicity study with Daphnia was conducted and resulted in a 48 hour EL50 of 41 mg/L loading rate WAF, and a NOEC of 32 mg/L loading rate WAF. A standard acute toxicity study with fish was conducted with FeMn slag as a limit test at 100 mg/L loading rate WAF and showed no effects. Therefore the 96 Hour LL50 was greater than 100 mg/L loading rate WAF and the NOEC was 100 mg/L loading rate WAF. A standard study on algae resulted in 72hr ErL50 90 mg/L loading rate WAF, EyL50 = 39 mg/L loading rate WAF, NOEC = 10 mg/L loading rate WAF, whilst an 8 day chronic study on daphnia gave NOEC = 3.2 mg/L loading rate WAF.

STP

No effects on sewage sludge were observed in a standard 3 hour study on FeMn Slag. Hence the NOEC for FeMn slag is 1000mg/L

Sediment

No experimental data on sediment toxicity exist. The data are not required as the hazard assessment performed during the chemical safety assessment concludes that the substance is not classified and is of no immediate concern to the environment.PNEC sediment is calculated by the equilibrium partitioning method.

Terrestrial

No experimental data on terrestrial toxicity exist. The data are not required as the hazard assessment performed during the chemical safety assessment concludes that the substance is not classified and is of no immediate concern to the environment.PNEC soil is calculated by the equilibrium partitioning method.

 

Conclusion on classification

According to the 2nd ATP to the CLP Regulation (EU) No 286/2011, the methodology for determining the environmental classification of metal compounds that have limited solubility, is based on the assumption that the ecotoxicological effects are determined by the fraction of dissolved metal. On this basis, relevant ecotoxicological information generated with a soluble metal compound expressed in terms of mg metal ion per litre) are compared with the level of metal ion released from the sparingly

soluble metalcompound under investigation (as determined during transformation/dissolution protocol testing).

The relevant ecotoxicological values (environmental reference values, ERV) for manganese were established by considering the database of available studies conducted with soluble manganese compounds (i.e. manganese dichloride, manganese sulphate, and manganese nitrate). The database was refined through application of suitable relevance and reliability criteria. From the resulting studies, the short term toxicity study with the lowest L(E)C50 was selected as the acute ERV for manganese (3.2 mg Mn/L; Davies & Brinkman, 1998 - Rainbow trout study with MnSO4), and the long term toxicity study with the lowest NOEC was selected as the chronic ERV for manganese (0.55 mg Mn/L; Davies & Brinkman, 1998 - Brook trout study with MnSO4). Both studies were conducted on standard species, and were assessed to be of adequate relevance and reliability for use in hazard determination of manganese. Summaries of these studies are included in this dataset.

The acute and chronic ERV values were compared to the levels of Mn release, as determined through transformation/dissolution protocol testing with Slags, ferromanganese-manufg. (Rodriguez, 2010). During the transformation/dissolution protocol test with Slags, ferromanganese-manufg., at initial test substance loading rates of 1, 10 and 100 mg/L, the level of manganese measured in the pH 6 media, following a 7 day exposure period, were 204.3, 1556.3 and 8810.1 µg Mn/L, respectively. The level of manganese measured in the pH 6 media following 28 days exposure, at the 1 mg/L test material loading rate, was 199.7 µg Mn /L.

Since the level of Mn release following a 7 day exposure of Slags, ferromanganese-manufg. to environmentally relevant water, at all three loading rates, was lower than the acute ERV, Slags, ferromanganese-manufg. does not require classification in terms of acute aquatic toxicity. Since the level of Mn release following a 28 day exposure of Slags, ferromanganese-manufg. to environmentally relevant water, at a loading rate of 1 mg/L, was lower than the chronic ERV, Slags, ferromanganese-manufg. does not require classification in terms of chronic aquatic toxicity.