Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 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:
0.087 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 mg/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:
0.069 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.2 mg/kg food
Assessment factor:
30

Additional information

Conclusion on classification

Classification and labelling has been based upon the key information for the ecotoxicity endpoints. The results of these studies are as follows:

96 hour LC50 (fish): > 11.4mg/l (Steger-Hartmann. T, Wendt. B 1998/DBT-2EHMA)

48 hour EC50 (Daphnia): 2 mg/l (Steger-Hartmann, T. & Schmidt, M. 1998/DBTO)

21 d NOEC (Daphnia): 0.098 mg/l (de Roode D. F. and de Haan H. P. M. 2004/DBT-2EHMA)

72 hour EC50 (algae): >1.6 mg/l (Steger-Hartmann, T, 1999/DBTO)

It should also be considered that the substance does not meet the definition of a readily biodegradable substance according to read across information from various other organotin substances.

The lowest of these results is the 21 day NOEC for Daphnia (de Roode and de Haan 2004), and this end-point has been used for classification and labelling and this meets the criteria under 67/548/EEC and EC Regulation 1272/2008 as follows:

67/548/EEC:

R51 and R53: Toxic to aquatic organisms and May cause long-term adverse effects to the aquatic environment.

EC Regulation 1272/2008: Hazardous to the aquatic environment, Chronic: Category 2; H411 Toxic to aquatic life with long lasting effects

However, in line with the Summary Record of the Technical Committee on the Classification and Labelling of Dangerous Substances, Meeting on Environmental Effects of Existing Chemicals, Pesticides and New Chemicals, JRC Ispra – January 25 2007, the Final Conclusion reached by the ECB was that salts should be classified as N, R50-53 and hence based on the Committee's decision we consider this the overriding classification for this substance.

 Classification/S-phrases  Toxicity  Degradation  Bioaccumulation  Escape clause

 N; R50 -53

S60 -61

0.01 <

L (E) C50

1.0 (mg/l) (based on read-across) 

 Not readily degradable (based on read-across)    Not relevant
 Specific concentration limits: Not applicable          

Therefore the substance is assigned the following classifications:

67/548/EEC:

R50 and R53: Toxic to aquatic organisms and May cause long-term adverse effects to the aquatic environment.

EC Regulation 1272/2008:

Hazardous to the aquatic environment, Acute: Category 1 and Chronic: Category 1