Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.11 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.