Registration Dossier
Registration Dossier
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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.11 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1.1 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.011 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.66 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.066 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:
- no potential for bioaccumulation
Additional information
Isobutyl-R-lactate has a low potential for adsorption to sediment and soil and is readily biodegradable. Acute aquatic toxicity test results for isobutyl-S-lactate were used in the risk assessment since chronic data were neither available for isobutyl-R-lactate nor for the optical antipode isobutyl-S-lactate. While aquatic toxicity against aquatic invertebrates and algae is covered by experimental results, the short-term toxicity of isobutyl-R-lactate against fish was estimated by validated QSAR models. One of these calculations revealed the lowest effect value across all trophic levels (96 -h LC50 of 108 mg/L) and was therefore selected for PNEC derivation. In an activated sludge respiration inhibition study an EC50 of >1000 mg/L was determined. Therefore, isobutyl-R-lactate is not considered to elicit any adverse effects against STP organisms that would identify a relevant hazard and may justify PNEC derivation for regulatory purposes.
Conclusion on classification
Isobutyl-R-lactate has a low potential for adsorption to sediment and soil and is readily biodegradable. In aquatic toxicity tests, the test item did not reveal any LC50/EC50 values below 100 mg/L, and would thus not be classified as hazardous to the aquatic environment in accordance with Section 4.1.2.6., Annex I of Regulation 1272/2008/EC.
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