Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The published study results were generated according to OECD guideline 201 "Alga, Growth Inhibition Test”, the EPA Guideline EG-8 and the Technical Support Document ES-5 and in compliance with GLP standards. The test substance is isobutyl-(S)-lactate, which is used for read-across. Since the test substance is the optical antipode of the target compound isobutyl-(R)-lactate and results for short-term toxicity in algae can be extrapolated, read-across is fully justified.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline EG-8 and the Technical Support Document ES-5
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Version / remarks:
- Test conditions followed ISO 8692.
- Deviations:
- not specified
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- not specified
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name:
- Strain: ATCC 22662
- Source (laboratory, culture collection): American Type Culture Collection, 12301 Parklawn Drive, Rockville, Maryland, U.S.A. - Test type:
- static
- Water media type:
- not specified
- Limit test:
- no
- Total exposure duration:
- 72 h
- Remarks on exposure duration:
- Various lactate esters were tested over 72 and 96 h. Since not explicitly stated in the documentation, it is not clear which period was applied to isobutyl-(S)-lactate. Therefore, 72 h is assumed as a worst-case.
- Test temperature:
- 20 ± 1 °C
- pH:
- 8.0
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 200 ml conical test flask
- Type: open
- Fill volume: 100 ml
- Initial cells density: 10^4 cells/ml
GROWTH MEDIUM
- Standard medium used: no
- Detailed composition if non-standard medium was used: The standard test medium was modified by adding 150 mg/L NaHCO3 and 80 mg/L Fe citrate × 3H2O for increasing buffer capacity and Fe availability for algal growth.
OTHER TEST CONDITIONS
- Adjustment of pH: pH 8.0
- Photoperiod:
- Light intensity: 80-86 µmol/s m²
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: Electronic particle counter (Coulter Counter Model TAII, 100 µm aperture) - Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 520 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95 % CI = 350-770
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- not specified
- Remarks on result:
- other: The NOEC is < 32 mg/L
- Validity criteria fulfilled:
- not specified
- Conclusions:
- For S. capricornutum strain ATCC 22662, an ErC50 value (based on growth rate) of 520 mg/L (95 % CI = 350-770 mg/L) was determined. The NOEC was found to be 32 mg/L.
- Executive summary:
In a 72–96 hour acute toxicity study, cultures of green algae (S. capricornutum, strain ATCC 22662) were exposed to isobutyl-S-lactate at nominal concentrations (not reported in detail) under static conditions in accordance with OECD guideline 201. The NOEC and EC50 values based on cell density were 32 and 520 mg/L, respectively. Abnormalities were not reported.
This toxicity study is classified as acceptable and satisfies the guideline requirements for algal growth inhibition studies.
Results synopsis
Test organism: Selenastrum capricornutum, strain ATCC 22662
Test type: Static
72 or 96 hr ErC50: 520 mg/L (95 % CI = 350 to 770 mg/L)
72 or 96 hr NOEC: 32 mg/L
Endpoint(s) effected: Growth rate
This result can be extrapolated to the target substance isobutyl-(R)-lactate without restrictions, which is the optical antipode of the test substance isobutyl-(S)-lactate.
Reference
The ErC50value – based to the growth rate of the algae – wass calculated using a parametric model following Kooijman. The NOEC is calculated by comparing the treatment results with the controls. In doing so, a limit of 10 % effect has been applied as significant deviation.
Description of key information
An ErC50 value (based on growth rate) of 520 mg/L (95 % C.I. 350–770 mg/L) was determined. The NOEC was 32 mg/L.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 520 mg/L
- EC10 or NOEC for freshwater algae:
- 32 mg/L
Additional information
In 72 h and 96 h hour short-term toxicity studies, cultures of S. capricornutum (strain: ATCC 22662) were exposed to the test item under static conditions in accordance with the OECD guideline 201 (Alga, Growth Inhibition Test), the EPA guideline EG-8 and the Technical Support Document ES-5, and the ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum). The actual test duration (72 or 96 hours) for isobutyl-(S)-lactate is not apparent from the study documentation. Therefore a test period of 72 h is assumed. An ErC50 value (based on growth rate) of 520 mg/L (95 % CI = 350–770 mg/L) was determined. The NOEC was found to be 32 mg/L.
This result can be extrapolated to the target substance isobutyl-(R)-lactate without restrictions, which is the optical antipode of the test substance isobutyl-(S)-lactate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.