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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:18, 32, 56, 100 and 180 mg/L
- At t = 24 h samples were taken from the control medium and from the freshly prepared test solutions of 18, 32 and 56 mg/L. At t = 48 h samples of the "spent" control medium and the same "spent" test solutions were taken.
- Sampling method: Samples of 50 mL were taken in 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 1 gram was accurately weighed out and dissolved in 1 litre DSWL. Portions of 27, 48, 84, 150 and 270 mL were each diluted to 1.5 litre, resulting in test solutions of 18, 32, 56, 100 and 180 mg/L. New concentrated solutions were prepared daily throughout the test period.
- Controls: DSWL
- 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):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra fish
- Strain: No data
- Source: M.B. Ruysbroek B.V. (Noordvliet 159, Maassluis)
- Length at study initiation: 2.1 ± 0.17 cm
- Weight at study initiation: 0.07 ± 0.018 g
- Method of breeding: No data
- Feeding during test: No
ACCLIMATION
No information provided. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- No
- Hardness:
- 220 mg/L.
- Test temperature:
- 24.2–24.7 °C
- pH:
- 7.8–8.2; at the beginning and at the end of the test and at each replacement time (in the spent solutions just after replacement and in the newly prepared solutions just after dosing) the pH and the oxygen concentration of the test solutions and control medium were measured. They were also measured after 2 h in the test solutions of 180 mg/L because all animals had died.
- Dissolved oxygen:
- 5.8-8.6 mg/L; At the beginning and at the end of the test and at each replacement time (in the spent solutions just after replacement and in the newly prepared solutions just after dosing) the pH and the oxygen concentration of the test solutions and control medium were measured. They were also measured after 2 h in the test solutions of 180 mg/L because all animals had died.
- Nominal and measured concentrations:
- See table 1.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 2000 mL glass beakers, each containing 1500 mL of test solution or control medium
- Type (delete if not applicable): open
- Aeration: The test solutions and control medium were slightly aerated and replaced daily.
- Renewal rate of test solution (frequency/flow rate): once a day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1; one beaker containing 10 fishes was used for each test solution and the control medium.
- No. of vessels per control (replicates): 1; one beaker containing 10 fishes was used for each test solution and the 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 Brachydanio rerio.
- Total organic carbon: 2 mg/L
- 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
OTHER TEST CONDITIONS
- Adjustment of pH: NA
- Photoperiod: The test was carried out under a 16 h light-8 h dark regime with transition periods of 30 minutes in a temperature controlled room of 25 ± 1°C.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality (LC50 and NOEC)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: yes, appropriate concentrations were determined in a preliminary range finding test
- Test concentrations: Five concentrations of butyl-(S)-lactate were tested. DSWL was used as a control medium. A quantity of 1 gram was accurately weighed out and dissolved in 1 litre DSWL. Portions of 27, 48, 84, 150 and 270 mL were each diluted to 1.5 litre, resulting in test solutions of 18, 32, 56, 100 and 180 mg/L. New concentrated solutions were prepared daily throughout the test period.
- Results used to determine the conditions for the definitive study: yes
Dead animals were counted and removed after 24 h, 48 h, 72 h and 96 h. At the same times the condition (swimming behaviour, colour, respiratory function or any other observable morphological or visual behavioural criterion) of the survivors was visually compared with that of the control animals. At t = 2 h all test vessels were also checked for mortality and the dead animals counted and removed. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 56–100 mg/L
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: condition
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 2 h
- Dose descriptor:
- LC50
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 72–100 mg/L
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 56–100 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 56–100 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL: 56–100 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 42.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: actual concentration
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: The average actual concentration was 57 % of the nominal concentration during the test.
- Details on results:
- - Mortality of control: no
- Other adverse effects control: none
- Abnormal responses: records of number of fish and their condition are recorded in table 2
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: substance completely dissolved in all concentrations
- Effect concentrations exceeding solubility of substance in test medium: n/a - Results with reference substance (positive control):
- -
- Reported statistics and error estimates:
- The maximum likelihood estimates of the LC50 values were calculated assuming a log-logistic dose-effect relation. Likelihood-ratio confidence intervals were derived from the confidence intervals.
- Sublethal observations / clinical signs:
Table 1: Measured concentrations of butyl (S)-lactate
Nominal concentration of test substance [mg/L]
Measured concentrations
t = 0 h
t = 48 h
mg/L
% of nominal
mg/L
% of nominal
0
> 1
< 1
18
14
78
5
28
32
26
81
11
34
56
46
82
23
41
Average % of nominal concentration at t = 0 h and t = 48 h
80
34
Average % of nominal during the test
57
Table 2 –Number of surviving fishes at several concentrations of butyl-(S)-lactate and after several exposure times
Time
(h)
Nominal concentration of the test substance (mg/L)
0
18
32
56
100
180
0
2
24
48
72
96
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
2
0
0
0
0
10
0
0
0
0
0
Table 3 –Number of fishes and their condition at several concentrations of butyl-(S)-lactate and after several exposure times
Time
(h)
Nominal concentration of the test substance (mg/L)
0
18
32
56
100
180
0
2
24
48
72
96
10(a)
10
10(a)
10(a)
10(a)
10(a)
10(a)
10
10(b)
10(b)
10(b)
10(b)
10(a)
10
10(b)
10(b)
10(b)
10(b)
10(a)
10
10(b)
10(b)
10(b)
10(b)
10(a)
2
2(c)
8(d)
0
2(d)
0
0
0
10(a)
0
10(d)
0
0
0
0
The following codes are used to denote condition:
(a)Condition of all fishes, visually assessed, normal (=good);
(b)Condition of all fishes, visually assessed, equal to that of the control fishes;
(c)Number of slow swimming fishes.
(d)Number of dead fishes
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96-h LC50 of butyl-(S)-lactate to Brachydanio rerio was determined to be 42.8 mg/L (measured concentration). The NOEC was 32 mg/L.
- Executive summary:
The 96 h acute toxicity of butyl-(S)-lactate to the fresh-water fish species Brachydanio rerio was determined as described in the OECD Guideline no. 203 and according to the OECD principles of Good Laboratory Practice.
The test was carried out as a semi-static test with daily replacement of the test solutions and with 10 fishes for each concentration. The exposure duration was 96 hours. The nominal concentrations tested were 18, 32, 56,100 and 180 mg/L. The test substance appeared to be completely dissolved at all concentrations tested (visually assessed). The actual concentrations of butyl-(S)-lactate were determined with gas chromatography (direct injection, FID detection). They were between 78 % and 82 % of the nominal concentrations just after dosing (average 80 %). To test the stability of the test substance the concentrations of butyl-(S)-lactate were also analysed after 24 h and appeared to be between 28 % and 41 % of the nominal concentrations (average 34 %). The average actual concentration was 57 % of the nominal concentration during the test.
Results synopsis
Test organism size/age (mean wet weight or length): The average total length and weight (± standard deviation) were 2.1 ± 0.17 cm and 0.07 ± 0.018 g respectively.
Test type: Semi-static
The results of the test were (as nominal concentrations):
48h LC50 (mortality): 75 mg/L
96h LC50 (mortality): 75 mg/L
96h LC100 (mortality): 100 mg/L
96h NOEC (mortality = 96h-LC0): 56 mg/L
96h NOEC (condition): 56 mg/L
The average actual concentration was 57 % of the nominal concentration during the test. Adjusted ECx values are the following:
48h LC50 (mortality): 42.8 mg/L
96h LC50 (mortality): 42.8 mg/L
96h LC100 (mortality): 57 mg/L
96h NOEC (mortality = 96h-LC0): 32 mg/L
96h NOEC (condition): 32 mg/L
Endpoints affected: Mortality, other effects (i.e. swimming behaviour, colour, respiratory function or any other observable morphological or visual behavioural criterion)
- Endpoint:
- short-term toxicity to fish
- 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 attached report in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 75 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95 % CL = 56–100 mg/L
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- 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
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No data
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- LC50 values and their 95 % confidence interval for survival in the fish test were calculated by means of a parametric model developed by Kooijman (1981) or, if too few concentrations showed partial mortality, by assuming a log-logistic dose-effect relation (van der Hoeven, 1991).
- Validity criteria fulfilled:
- not specified
- Remarks:
- Poor documentation, validity cannot be assessed
- Conclusions:
- The short-term toxicity testing of butyl lactate on freshwater fish (Danio rerio) resulted in an LC50 (96 h) of 75 mg/L (nominal).
- Executive summary:
In a 96-h acute toxicity study, zebra fish (Danio reriosyn.Brachydanio rerio) were exposed to butyl lactate at nominal concentrations of 0 (control), 320 and 560 mg/L (further information on the number of concentration levels not available) under semi-static conditions. The 96-h LC50 was 75 mg/L. The NOEC value, based on mortality, was 56 mg/L. Sublethal effects were not reported. Based on the results of this study, butyl 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 a fish short-term toxicity study but can nevertheless be used as supportive data.
Results synopsis
Test organism: Zebra fish (Danio rerio, Brachydanio rerio)
Test type: Semi-static
LC50: 75 mg/L (95 % CL = 56–100 mg/L)
NOEC: 56 mg/L
Endpoint(s) effected: Survival/mortality
This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
Referenceopen allclose all
Description of key information
In a guideline compliant study according to GLP, the LC50 of butyl-S-lactate for mortality of Brachydanio rerio was determined to be 75 mg/L (nominal). The test substance concentrations were analytically monitored and found to be maintained at 57 % of nominal during the test. Therefore, the LC50 value was adjusted to 42.8 mg/L.
This result is confirmed by published results.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 42.8 mg/L
Additional information
The following LC50 values were determined for fish:
LC50 (96h, Brachydanio rerio) = 75 mg/L (Hooftman 1992, according to OECD 203)
LC50 (96h, Brachydanio rerio) = 75 mg/L (Bowmer 1998, according to OECD 203)
The LC50 value for butyl-S-lactate reported by Hooftman (1992) is used as key value. The study is guideline and GLP compliant. The test substance concentrations were analytically monitored and found to be maintained at 57 % of nominal during the test. Therefore, the LC50 value was adjusted to 42.8 mg/L.
As supporting study LC50 values reported by Bowmer (1998) are presented. Due to insufficient documentation it is not clear which isomer of butyl lactate was used in the publication.
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