Germanium, germanium hydroxide oxides and amorphous silica, recovery products from germanium refining

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Automatic calculation with MeCLas Tool

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: software

Title:

RESHS MECLAS: Metals Classification Tool, version V5.0

Author:

ARCHE Consulting

Year:

2018

Bibliographic source:

MECLAS webpage: www.meclas.eu

Report date:

2018

Materials and methods

Principles of method if other than guideline:

Aquatic toxicity of the UVCB substance was determined by classifying based on Mixture rules from EU CLP (tier 1= summation of classified components or Tier 2 = additivity of soluble components to derive Hazard class) and back calculation to the corresponding L(E)C50 range

Test material

Test material information

Constituent 1

Reference substance name:

Germanium dioxide

EC Number:

215-180-8

EC Name:

Germanium dioxide

Cas Number:

1310-53-8

Molecular formula:

GeO2

IUPAC Name:

Germanium dioxide

Constituent 2

Reference substance name:

Germanium

EC Number:

231-164-3

EC Name:

Germanium

Cas Number:

7440-56-4

Molecular formula:

Ge

IUPAC Name:

germanium (metallic form) equivalent

Constituent 3

Reference substance name:

Silicon dioxide

EC Number:

231-545-4

EC Name:

Silicon dioxide

Cas Number:

7631-86-9

Molecular formula:

O2Si

IUPAC Name:

dioxosilane equivalent

Constituent 4

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Constituent 5

Reference substance name:

Aluminium oxide

EC Number:

215-691-6

EC Name:

Aluminium oxide

Cas Number:

1344-28-1

Molecular formula:

Al2O3

IUPAC Name:

Aluminium oxide equivalent

Constituent 6

Reference substance name:

Calcium oxide

EC Number:

215-138-9

EC Name:

Calcium oxide

Cas Number:

1305-78-8

Molecular formula:

CaO

IUPAC Name:

Calcium oxide equivalent

Constituent 7

Reference substance name:

Lead oxide

EC Number:

215-626-1

EC Name:

Lead oxide

Cas Number:

1335-25-7

Molecular formula:

PbO

IUPAC Name:

Lead oxide equivalent

Constituent 8

Reference substance name:

Nickel monoxide

EC Number:

215-215-7

EC Name:

Nickel monoxide

Cas Number:

1313-99-1

Molecular formula:

NiO

IUPAC Name:

Nickel (II) oxide equivalent

Constituent 9

Reference substance name:

Copper oxide

EC Number:

215-269-1

EC Name:

Copper oxide

Cas Number:

1317-38-0

Molecular formula:

CuO

IUPAC Name:

copper (II) oxide equivalent

Test material form:

solid

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

<= 1 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

other: most sensitive species

Any other information on results incl. tables

Sublethal observations / clinical signs:

According to MeClas, the substance is classified as toxic category 1 to environment (acute).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Good quality estimate of the L/EC50 of the UVCB substance.
The substance is classified as acute cat 1 to environment resulting in a L(E)C50 <= 1 mg/L.

Executive summary:

The study provided a conservative estimate of the effect concentration, derived on basis of the classification outcome (mixture toxicity rules) from a reasonable worst-case sample of the substance using mineralogical information from the representative sample. 

 

Validity of the model used:

1. Defined endpoint: the endpoint is a REACH compliant defined endpoint

2. Unambiguous algorithm: EU CLP guidance based summation formula to determine classification, followed by back-calculation to related hazard criteria

3. Applicability domain: applicable to classify complex metal containing materials. 

4. Mechanistic interpretation - metal species: the tool translates the elemental composition into a mineralogical composition relevant for classification.