Registration Dossier
Registration Dossier
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EC number: 233-117-2 | CAS number: 10039-33-5
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 1 mg/L
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:
- 38 040 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 3 804 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:
- 7 577.6 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The toxicity potential of the substance to the aquatic organisms was evaluated by considering available data on two analogue substances, due to the absence of data for the target substance. Justification for Read Across is given in Section 13 of IUCLID.
The aquatic toxicity studies include the short-term toxicity to fish and to aquatic invertebrates, the toxicity to aquatic algae and the toxicity to microorganisms. It is worth saying that no toxic effect levels were observed up to the water solubility of the substance. The following results are obtained:
Fish
LC50 (96 h) > 0.09 mg/l (measured, geom. mean)
Daphnia
EC50 (48 h)> 0.21 mg/l (measured, geom.mean)
Algae
ErC50 (72 hrs) > 0.0018 mg/l (measured, initial)
Microorganisms
EC50 (3h)> 1000 mg/l (nominal)
Conclusion on classification
No toxic effects on aquatic organisms were observed up to the water solubility of the substance and therefore the substance is not considered to exhibit an aquatic toxicity potential.
Classification for Acute Aquatic Toxicity or for Chronic Toxicity Category 1, 2 or 3 is not proposed.
According to the CLP Regulation (EC) No. 1272/2008, Chronic Category 4 - safety net concerns the cases when data do not allow classification under the criteria for classification in the categories aforementioned, but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable and have an experimentally determined BCF ≥ 500 (or, if absent, a log Kow > 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in Section 4.1.2.9.5. of CLP Regulation.
The substance does not present any toxic effects up to the water solubility, it is practically insoluble in water, it has a predicted BCF value lower than 500 but a predicted logKow much higher than 4 and it is not readily-biodegradable. The hydrolytic potential of the substance was not studied considering the high insolubility of the substance but the presence of two ester group suggests that the substance could be hydrolysed to dioctyltin oxide (insoluble) and to (2-ethylhexyl maleate) which is classified as Aquatic Chronic 1. Considering the aforementioned and following a precautionary approach, the substance is classified in Aquatic Chronic Category 4 (H413).
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