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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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).

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

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

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.

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

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.