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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 252-036-3 | CAS number: 34451-19-9
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-08-08 to 1992-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100, 180, 320, 560 and 1000 mg/L
- At t = 0 h samples were taken from the control medium and from the freshly prepared solutions of 100, 320 and 1000 mg/L. At t = 24 h samples of the "spent" solutions of 1000 mg/L were taken (all animals died at that concentration). At the end of the test samples of the "spent" control medium and the "spent" solutions of 100 and 320 mg/L were taken.
- Sampling method: Samples of 50 mL were taken in 250 mL glass bottles and immediately transported under cooled conditions to the analytical department of TNO
- Sample storage conditions before analysis: Refrigerated - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Five concentrations of butyl-(S)-lactate were tested. DSWL was used as a control medium. A quantity of 2 grams was accurately weighed out and dissolved in 2 litres DSWL. This solution of 1000 mg/L was used as the highest test concentration and to prepare the other test solutions. Therefore 100, 180, 320 and 560 mL were diluted to 1000 mL, resulting in test solutions of 100, 180, 320 and 560 mg/L.
- Controls: NA
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no, freshly prepared solutions of the test substance appeared to be completely dissolved (visually assessed) at all concentrations tested throughout the test - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Not applicable
- Source: In-house culture
- Age at study initiation: < 24 h
- Feeding during test: No
- Food type: Not applicable - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- 220 mg/L (CaCO3)
- Test temperature:
- 20.0–19.9 °C
- pH:
- 7.6–8.2
- Dissolved oxygen:
- 7.0–9.1 mg/L
- Nominal and measured concentrations:
- See table 1
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 150 mL glass beakers, each containing 100 mL of test solution or control medium
- Type: Open
- Material, size, headspace, fill volume: See above
- Aeration: No
- Type of flow-through: n/a
- Renewal rate of test solution (frequency/flow rate): Static
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4, four beakers containing 5 daphnias each were used for each test solution or control medium.
- No. of vessels per control (replicates): 4, four beakers containing 5 daphnias each were used for each test solution or control medium.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water used was DSWL, prepared from ground water. This DSWL has proven to be suitable for the culture of Daphnia magna.
- Total organic carbon: 2.0 mg/L
- Culture medium different from test medium: No
- Metals: Na 1.26 mmol/L, K 0.23 mmol/L, Ca 1.41 mmol/L , Mg 0.78 mmol/L
- Chlorine: 2.81 mmol/L
- Intervals of water quality measurement: Measured in the beggining and in the end of the test (0 and 48 h). pH and oxygen concentrations were also measured after 24 h in the test beakers in which all animals were immobile.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light 8 h dark with transition periods of 30 minutes
- Light intensity: No data
EFFECT PARAMETERS MEASURED: Mobility; the immobile animals were counted after 24 hours and at the end of the test according to the definition given in the OECD guideline no. 202. At the same time the condition (swimming behaviour, colour or any other visual observable morphological or behavioural criterion) of the mobile animals was visually compared with that of the control animals.
TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: The range-finding study was performed, however no details were reported
- Results used to determine the conditions for the definitive study: Appropriate concentrations were determined in a preliminary range-finding test. - Reference substance (positive control):
- no
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 423 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CL = 320–560 mg/L
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 560 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Not reported
- Observations on body length and weight: No
- Mortality of control: No
- Other adverse effects control: None
- Abnormal responses: Not reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test substance totally dissolved
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- The maximum likelihood estimates of the EC50 values were calculated assuming a log-logistic dose-effect relation. Likelihood-ratio confidence intervals were derived from the confidence intervals according to van der Hoeven, N. (1991: LC50 estimates and their confidence intervals derived for tests with only one concentration with partial effect. Water Res. 25,401-408).
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-h EC50 of butyl-S-lactate to Daphnia magna is 423 mg/L (nominal).
- Executive summary:
The 48-h acute toxicity of butyl-S-lactate to Daphnia magna was studied under static conditions as described in the OECD Guideline no. 202 and according to the OECD principles of Good Laboratory Practice.
Test organisms were exposed to a control, and the test chemical at nominal concentrations of 100, 180, 320, 560 and 1000 mg/L for 48 hours. Mortality/ immobilisation and sublethal effects were observed daily.
The test substance appeared to be completely dissolved at all concentrations tested (visually assessed). Test substance concentrations were analytically monitored and found to be maintained at 80 % of nominal during the test. Therefore, referring to nominal effect values is appropriate.
The 48-hour EC50 was 423 mg/L. The 48-hr NOEC based on immobilisation was 320 mg/L (nominal). The sublethal effects included were colour and any other visually observable morphological or behavioural criteria.
Based on the results of this study, butyl-S-lactate would not be classified as toxic to Daphnia magna in accordance with the classification system of the EU CLP Regulation.
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Results synopsis
Test organism age: Neonates
Test type: Static
The results of the test were (in nominal concentrations):
NOEC: 320 mg/L
EC50: 423 mg/L (95% C.I.: 320 to 560 mg/L)
Endpoint(s) effected: Mobility
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 320 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CL = 320 - 399
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 423 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CL = 320 - 560
- Details on results:
- - Behavioural abnormalities: No data
- Observations on body length and weight: No data
- Other biological observations: No data
- Mortality of control: No data
- Other adverse effects control: No data
- Abnormal responses: No data
- Effect concentrations exceeding solubility of substance in test medium: No - Validity criteria fulfilled:
- not specified
- Conclusions:
- The short-term toxicity testing of lactic acid on freshwater invertebrates (Daphnia magna) resulted in an EC50 (48 h) of 320 and 423 mg/L.
- Executive summary:
In a 48-h acute toxicity study, water fleas (Daphnia magna) were exposed to butyl-(S)-lactate at nominal concentrations of 0 (control), 180, 320 and 560 mg/L (further information on the number of concentration levels not available) under static conditions. The 48-h EC50 was 423 mg/L. Sublethal effects were not reported. Based on the results of this study, butyl-(S)-lactate would not be classified as hazardous to the aquatic environment according to the CLP Regulation (EC) No 1272/2008.
This toxicity study is classified as supplementary information and does not satisfy the guideline requirement for an invertebrate short-term toxicity study but can nevertheless be used as supportive data or in a weight-of-evidence approach.
Results synopsis
Test organism: Water flea (Daphnia magna)
Test type: Static
EC50: 320 and 423 mg/L (95 % CL = 320–399 and 320–560)
NOEC: 180 mg/L
Endpoint(s) effected: Mobility
Referenceopen allclose all
Table 2 - Number of mobile animals at several concentrations of butyl-(S)-lactate and after several exposure times
Time |
Nominal concentrations of test substance (mg/L) |
|||||
0 |
100 |
180 |
320 |
560 |
1000 |
|
0 24 48 |
20 20 20 |
20 20 20 |
20 20 20 |
20 20 20 |
20 7 0 |
20 0 0 |
The average measured concentrations of lactate esters were generally between 70 and 80 % of the nominal concentrations in both the newly prepared and spent test media during the fish and D. magna tests.
Description of key information
In a guideline compliant study according to GLP, the EC50 of butyl-S-lactate for immobilisation of Daphnia magna was determined to be 423 mg/L. This result is confirmed by published results.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 423 mg/L
Additional information
Hooftman et al. (1992) report the EC50 for immobilisation of Daphnia magna by butyl-(S)-lactate to be 423 mg/L. Test substance concentrations were analytically monitored and found to be maintained at 80 % of nominal during the test. Therefore, referring to nominal effect values is appropriate.
In a published study, Bowmer et al. (1998) report EC50 values for "butyl lactate" (i.e. of unspecified stereochemistry) of 423 and 320 mg/L, without further explanation. It is, however, quite evident that the proprietary report by Hooftman et al. (1992) and the Bowmer et al. (1998) paper are based on the same data. Therefore, the EC50 of 320 mg/L the nominal effect corrected by 70 % recovery of the test substance at test end (48 h). This procedure is not correct. Instead, the average measured concentration over the entire test period corresponds to 80 % of nominal. It is therefore appropriate to report effect values as nominal concentrations.
Based on these data the substance would not be classified as acutely or chronically toxic to aquatic invertebrates under the EU CLP Regulation.
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.