Potassium (S)-lactate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key 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

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

130 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 56 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: The abnormal effects of mortality, surfacing and/or loss of equilibrium were observed in the 100, 180 and 320 mg/1 test concentrations during the 96 hour exposure period.
- Observations on body length and weight: not reported
- Mortality of control: none
- Other adverse effects control: /
- Abnormal responses:/
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: yes, observed in the concentrations of 0.000042, 0.000075, 0.00014 mg/L
- LC50: 96-hour LC50 4.8E-5 mg/L

Sublethal observations / clinical signs:

The 24, 48 and 96 hour LC₅₀ values of SY-83 to rainbow trout (Salmo gairdneri) were 150, 130 and 130 mg/L, respectively. All results were based on the nominal concentrations of 32, 56, 100, 180 and 320 mg/L. The no-effect concentration (NOEC) based on the lack of mortality and abnormal effects after 96 hours of exposure was 56 mg/L. The abnormal effects of mortality, surfacing and/or loss of equilibrium were observed in the 100, 180 and 320 mg/L test concentrations during the 96 hour exposure period. The rainbow trout were challenged with a reference compound, Antimycin A, to verify method precision. The 96 hour LC₅₀ for rainbow trout exposed to Antimycin A was 4.8 × 10^-5 mg/L and was within the 95 % confidence intervals reported in the literature [Berger, B. L., R. E. Lennon and J. W. Hogan. 1969. Laboratory Studies on Antimycin A as a fish toxicant. U. S. Department of Interior, Investigations in Fish Control No. 26. 21 p.] An examination of the fish culture and acclimation records for this test indicated that the fish were in good condition for testing.

The dissolved oxygen concentrations ranged from 6.1 to 9.2 mg/L during the test. These values represented 56 and 85 % saturation at 12 °C, respectively, and were considered adequate for testing. The pH values ranged from 3.5 to 7.3. The pH values decreased with higher test concentrations. The study was conducted following the intent of the Good Laboratory Practice Regulations and the final report was reviewed by Analytical Bio-Chemistry Laboratories' Quality Assurance Unit. All original raw data was provided to Union Oil Company, with a copy retained at Analytical Bio-Chemistry Laboratories.

Validity criteria fulfilled:

yes

Conclusions:

The determined 96 hour LC50 of SY-83 to rainbow trout is 130 mg/L (nominal concentration of test material). The 96 hour NOEC was determined at 56 mg/L (nominal concentration of test material).

Executive summary:

In a 96-h acute toxicity study,rainbow trout (Salmo gairdneri)were exposed to L(+)-lactic acid at nominal concentrations of 0 (control),32, 56, 100, 180 and 320 mg/Lunder static conditions. The 96-h LC₅₀was 130 mg/L. The NOEC value, based on mortality was 56 mg/L. Sublethal effects ofsurfacing and loss of equilibriumwere observed in the groups exposed to 100, 180 and 320 mg/L of L(+)-lactic acid.  Based on the results of this study, L(+)-lactic acid would not be classified as acute toxic toS. gairdneriin accordance with theCLP classification system.

This toxicity study is classified as acceptable and satisfies the guideline requirement for acute toxicity tests with fish, macroinvertebrates and amphibians according to the EPA-669/3-75-009 (1975) toxicity study.

Results synopsis

Test organism size/age (mean wet weight or length):Salmo gairdneri,mean weight of 1.09 (± 0.28) g and a mean standard length of 42 (± 3.4) mm

Test type: Static

LC₅₀: 130 mg/L (95% C.I.:  100–180 mg/L)

NOEL: 56 mg/L                            

Endpoint(s) dffected: Mortality, surfacing and loss of equilibrium.

Reference 2

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 read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reference substance (positive control):

yes

Remarks:

Antimycin A

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

130 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 56 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The 24, 48 and 96 hour LC50 values for SY-83 were 140, 130 and 130 mg/L, respectively. All results were based on the nominal concentrations of 56, 100, 180, 320 and 560 mg/L. The no-effect concentration based on the lack of mortality and abnormal effects after 96 hours of exposure was 56 mg/L. The abnormal effects of mortality and surfacing were observed in the 100, 180, 320 and 560 mg/L test concentrations during the 96 hour exposure period.
Examination of the fish culture and acclimation records for this test indicated that the fish were in good condition for testing.
The dissolved oxygen concentrations ranged from 5.6 to 9.0 mg/L during the test. These values represented 64 and 102 % saturation at 22 °C, respectively, and were considered adequate for testing. The pH values ranged from 3.1 to 7.2, with decreasing levels as test concentrations increased.

Results with reference substance (positive control):

The bluegill sunfish were challenged with a reference compound, Antimycin A, to verify method precision. The 96 hour LC50 for bluegill sunfish exposed to Antimycin A was 1.0E-4 mg/L and was within the 95 % confidence intervals reported in the literature.

Validity criteria fulfilled:

yes

Conclusions:

The 96 hour LC50 of L(+)lactic acid to bluegill sunfish was determined to be 130 mg/L. The 96 hour NOEC of L(+)lactic acid to bluegill sunfish was determined to be 56 mg/L.

Executive summary:

In a 96-h acute toxicity study, rainbow trout (Salmo gairdneri) were exposed to L(+)-lactic acid at nominal concentrations of 0 (control), 32, 56, 100, 180, and 320 mg/Lunder static conditions. The 96-h LC₅₀ was 130 mg/L. The NOEC value, based on mortality was 56 mg/L. Sublethal effects ofsurfacing and loss of equilibriumwere observed in the groups exposed to 100, 180, and 320 mg/L of L(+)-lactic acid.  Based on the results of this study, L(+)-lactic acid would not be classified as acutely toxic to S. gairdneri in accordance with the CLP classification system.

This toxicity study is classified as acceptable and satisfies the guideline requirement for acute toxicity tests with fish, macroinvertebrates and amphibians according to the EPA-669/3-75-009 (1975) toxicity study.

Results synopsis

Test organism size/age (mean wet weight or length): Salmo gairdneri,mean weight of 1.09 (± 0.28) g and a mean standard length of 42 (± 3.4) mm

Test type: Static

LC₅₀: 130 mg/L (95% C.I.:  100–180 mg/L)

NOEL: 56 mg/L                            

Endpoint(s) dffected: Mortality, surfacing, and loss of equilibrium.

Reference 3

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 read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

180 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

320 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 195 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Details on results:

Test solutions were not neutralised. It is more than likely that the low pH value affected the survival of the fish. At the highest test concentration a pH of 3.25 was measured.

Sublethal observations / clinical signs:

The apparent toxicity of lactic acid to Brachydanio rerio can be explained by the low pH values of the test substance solutions. At the highest test concentration a pH of 3.25 was measured.

Validity criteria fulfilled:

yes

Conclusions:

The LC50 of L-(+)-lactic acid to Danio rerio was determined to be > 195 mg/L (mean measured concentration), which can be attributed to a pH effect.

Executive summary:

The acute toxicity of the test substance, a solution of about 80 % L-(+)-lactic acid, to the freshwater fish speciesBrachydanio reriowas determined according to OECD guideline no. 203 and under GLP.

The study was carried out as a semi-static test with daily replacement of the test solutions and with 10 fish for each concentration. The exposure duration was 96 hours. The nominal concentrations tested were 100, 180, 320, 560 and 1000 mg/L.

The test substance appeared to be completely dissolved at all concentrations tested (visually assessed). The actual concentrations of L-(+)-lactic acid were determined enzymatically with a Boehringer test kit. They were between 70 and 77 % of the nominal concentrations just after dosing (average 74 %). To test the stability the concentrations of L-(+)-lactic acid were also analysed just before renewal and were between 56 % and 82 % of nominal (average 72 %). Mean measured effect concentrations are thus obtained by correcting nominal test material concentrations by correcting for 80 % lactic acid concent and by the average 72 % measured values.

The results of the test were (as mean measured concentration of L-(+)-lactate):

96-h LC50 > 195 mg/L

96-h LC100 = 332 mg/L

96-h NOEC (mortality) = 104 mg/L

The apparent toxicity of lactic acid toBrachydanio rerio can be explained by the low pH values of the test substance solutions. At the highest test concentration a pH of 3.25 was measured.

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.

Reference 4

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 read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

880 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

96 h LC50 (NaCl) = 6,390 mg/L
"Because toxicity testing of salt solutions was to be completed over several months, we recognized the possibility that systematic drift in test organism sensitivity could bias the results of toxicity tests conducted at different times. In an attempt to account for this potential variability, each set of toxicity tests included a reference toxicant test using NaCl. LC50 values were computed for each of these tests and were included in the statistical modeling as another independent variable. Thus, if drifts in organism sensitivity did occur and were reflected in the response to NaCl, they could be accounted for in the regression modeling."

Reported statistics and error estimates:

96 h LC50 = 880 mg/L; 95 % C.I. = 750-1020 mg/L

Sublethal observations / clinical signs:

The measured ion concentrations in the stock solution differed less than 20 % from nominal concentrations and, thus, calculations are based on nominal values.

To calculate ion concentrations in actual test solutions, the concentrations in the applicable stock solutions were multiplied by the relative proportion of each solution in the test solution. Because the dilution water (MHRW) also contained small concentrations of each ion, these background concentrations were then added to the calculated contributions from the stock solutions.

Validity criteria fulfilled:

not applicable

Conclusions:

Within the frame of analysing statistical models to predict the toxicity of major ions to Ceriodaphnia dubia, Daphnia manga and Pimephales promelas to toxicity of KCl to aquatic invertebrates was assessed. The study was conducted according to U.S. EPA national methods. Thus, the study can be evaluated as reliable and in accordance with REACH requirements.

Executive summary:

In a 96-h acute toxicity study, fathead minnow (Pimephales promelas) were exposed to KCl at nominal concentrations of control, reference substance (NaCl), and test chemical at appropriate nominal concentrations under static conditions. The 96-h LC₅₀ was 880 mg/L.  Based on the results of this study, KCl would not be classified as toxic to P. promelas in accordance with the classification system of the U.S. EPA.

This toxicity study is classified as supplementary and satisfies the guideline requirement for acute toxicity studies on fish.

Results synopsis

Test organism size/age (mean wet weight or length): Pimephales promelas, 1 to 7 days old

Test type: Static

LC₅₀: 880 mg/L (95 % C.I. = 750–1020 mg/L)

Endpoint(s) effected: Mortality, abnormal behaviour.

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.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary source and Japanese publication with English abstract, thus little information on the conduct of the experiments available.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Determination of the LC50 of pH to various salmonid species (Oncorhynchus mykiss, Salmo trutta, Salvelinus fontinalis, Salvelinus sp., Oncorhynchus rhodurus × masou) after 24 h exposure.

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

ca. 3.83 other: pH

Nominal / measured:

meas. (not specified)

Conc. based on:

other: pH

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

The short-term toxic effects of pH (H+ ions) on five fish species after 24 h exposure were investigated. The LC50 (24 h) in the rainbow trout (Oncorhynchus mykiss) is pH 3.83.

Executive summary:

In a 24-h acute toxicity study, rainbow trout (Oncorhynchus mykiss) were exposed to acidity at various measured concentrations (pH measurement), presumably under static conditions. The 24-h LC₅₀ was pH 3.83. Sublethal effects were not reported. Based on the results of this study, acidity can be considered to exhibit adverse effects on rainbow trout on a short time-scale (24 h) at pH of approximately 4 and lower.

This toxicity study is classified as supplementary information in the toxicity evaluation of acids; it does not satisfy the guideline requirement for a short-term toxicity study but can nevertheless be used as supportive data or in a weight-of-evidence approach.

Results synopsis

Test organism: Rainbow trout (Oncorhynchus mykiss)

Test type: Static

LC₅₀: pH 3.83

Endpoint(s) effected: Survival/mortality

Reference 6

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 read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

No data.

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: No data
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): No data
- Weight at study initiation (mean and range, SD): No data
- Method of breeding: No data
- Feeding during test: No data
- Food type: No data
- Amount: No data
- Frequency: No data

ACCLIMATION
- Acclimation period: No data
- Acclimation conditions (same as test or not): No data
- Type and amount of food: No data
- Feeding frequency: No data
- Health during acclimation (any mortality observed): No data

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

No data

Hardness:

No data

Test temperature:

No data

pH:

At 320 mg/L: pH 4.1
At 560 mg/L: pH 3.5

Dissolved oxygen:

No data

Salinity:

Not applicable - freshwater test.

Nominal and measured concentrations:

No data

Details on test conditions:

TEST SYSTEM
- Test vessel: No data
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: No data
- Aeration: No data
- Renewal rate of test solution (frequency/flow rate): No data; semi-static
- No. of organisms per vessel: No data
- No. of vessels per concentration (replicates): No data
- No. of vessels per control (replicates): No data
- Biomass loading rate: No data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: No data
- Total organic carbon: No data
- Particulate matter: No data
- Metals: No data
- Pesticides: No data
- Chlorine: No data
- Alkalinity: No data
- Ca/Mg ratio: No data
- Conductivity: No data
- Culture medium different from test medium: No data
- Intervals of water quality measurement: No data

OTHER TEST CONDITIONS
- Adjustment of pH: Not adjusted
- Photoperiod: No data
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: No data
- Range finding study: None

Reference substance (positive control):

not required

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 320 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % CL = 320-468

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 320 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, 95 % confidence interval (CI)

Sublethal observations / clinical signs:

The apparent toxicity of lactic acid to Danio rerio can be explained by the low pH values of the test substance solutions (pH 4.1 and 3.5 at concentrations of 320 and 560 mg/L respectively).

Validity criteria fulfilled:

not specified

Remarks:

Poor documentation, validity cannot be assessed

Conclusions:

The short-term toxicity testing of lactic acid on freshwater fish (Danio rerio) resulted in an LC50 (96 h) of 320 mg/L (nominal), which can be attributed to a pH effect.

Executive summary:

In a 96-h acute toxicity study, zebra fish (Danio rerio) were exposed to L-(+)-lactic acid 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 LC₅₀was > 320 mg/L. The observed effects can be attributed to a pH effect. The NOEC value, based on mortality effects, was 320 mg/L, respectively. Sublethal effects were not reported. Based on the results of this study, L-(+)-lactic acid 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 or in a weight-of-evidence approach.

Results synopsis

Test organism: Zebra fish (Danio rerio)

Test type: Semi-static

LC₅₀: > 320 mg/L

NOEC: 320 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.

Description of key information

Potassium lactate fully dissociates into K+ ions and lactate. The ecotoxicology of potassium-S-lactate can be understood in terms of the ecotoxicology of potassium chloride and lactic acid.

In short-term toxicity tests of lactic acid in three different fish species mortality was observed resulting in estimated LC₅₀ values ranging between 130 and > 320 mg/L (nominal), which can be attributed to a pH effect. Lactate as such is considered not exert any systemic effects on fish in the tested concentration range of up to 560 mg/L.

Mount et al. (1997) published a peer-reviewed study on the toxicity of several ionic compositions, including KCl, to Daphnia magna, Ceriodaphnia dubia, and Pimephales promelas, which is rated as Klimisch 2. The test with P. promelas was conducted similar to the OECD test guideline 203. The determined 96-h LC50 was 880 mg/L.

Overall, effect values describing the potential toxicity of potassium-S-lactate are far beyond the limits relevant for classification and labelling. Re-calculated to potassium lactate, the above effect values would result in an LC₅₀ in excess of 1000 mg/L. Therefore, a key value for chemical safety assessment cannot be identified. Potassium-S-lactate is not hazardous for fish.

Additional information

Potassium lactate fully dissociates into K+ ions and lactate. The ecotoxicology of potassium-S-lactate can be understood in terms of the ecotoxicology of potassium chloride and lactic acid.

The results of the cited studies are used in a read-across approach and cover both components of the target substance potassium-S-lactate. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.