Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.24 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
72.4 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.724 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
3.2 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification for environment is implemented according to the approach specified for metals outlined in the “Guidance on the Application of the CLP” (April, 2012).

Based on the solubility values obtained from the transformation/dissolution test and the respective Effect Reference Values (ERVs) for the compound the following classification for environmental hazards has to be assigned for Tellurium dioxide:

 

Effect Reference Values (ERVs):

 

 

Tellurium dioxide

Transformation/dissolution test:

Screening test:

24 hours, loading 100 mg/L

pH 6

pH 8

 

Main test:

pH 8, equilibrium after 7 day:

Loading 1mg/L

Loading 10 mg/L

Loading 100 mg/L

 

 

 

2.433 mg/L (Te) 

30.6 mg/L (Te)

 

 

698.9 µg/L (Te)

6.254 mg/L (Te)

30.72 mg/L (Te)

Short term toxicity to fish:

 

 

LC50 > 46.4 mg/L TeO2 (measured)

Short term toxicity to aquatic invertebrates:

 

EC50 7.24 mg/L TeO2

(measured)

Short term toxicity to aquatic alga and cyanobacteria

 

EC50 > 14.7 mg/L TeO2

NOEC 4.17 mg/L TeO2

(measured)

 

Data used as basis for classification and labelling:

Lowest acute ERV (effect reference value): Short term toxicity to aquatic invertebrates:

EC50 7.24 mg/L TeO2 (5.79 mg Te/L).

T/D data: 30.6 mg/L from Screening Test (loading 100 mg/L)

In the main study the equilibrium for Tellurium dioxide has been reached after 7 days (30.72 mg/L for loading of 100 mg/L) at the target pH of 8.

Classification is established according to guidance on CLP application 11-2013 –Annex IV classification of metals, citations are given in italic:

Classification strategies for metal compounds

A metal compound will be considered as readily soluble if:

  • the water solubility (measured through a 24-hour Dissolution Screening test or estimated e.g. from the solubility product) is greater or equal to the acute ERV of the dissolved metal ion concentration;

 

Tellurium dioxide: (T/D – 30.60 mg/L > lowest acute value of 5.79 mg/L)              

 

Where the acute ERV for the metal ions of concern corrected for the molecular weight of the compound (further called as acute ERVcompound) is greater than 1 mg/l, the metal compounds need not to be considered further in the classification scheme for acute hazard.

 

Tellurium dioxide: lowest acute ERVcompound of 7.24 mg/L

The surrogate approach

Readily soluble metal compounds

In absence of relevant chronic toxicity data, and unless there is evidence of both rapid environmental transformation and evidence of no bioaccumulation (see sections IV.3 and IV.4),

 

b) Category Chronic 2 if the acute ERVcompound > 1mg/l and ≤ 10 mg/l; or

Tellurium dioxide: (lowest acute ERVcompound of 7.24 mg/L)         

Conclusion on classification and labelling for environmental hazards:

Tellurium dioxide:         no classification for acute environmental hazards

                                           Category Chronic 2

(H411 – Toxic to aquatic life with long lasting effects)

 

M-factors are only applicable to the concentration of a substance classified as hazardous to the aquatic environment (categories Acute 1 and Chronic 1)...

Hazardous to the aquatic environment:

·       Acute/short-term: No classification required

·       Long-term: Aquatic Chronic 2
H411: Toxic to aquatic life with long lasting effects.