Calcium (S)-2-hydroxypropionate

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:

weight of evidence

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

Test organisms (species):

Lepomis macrochirus

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 9 500 - <= 11 300 mg/L

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

96 hours LC50 for three size ranges of fish
--------------------------------------------------
size (length, weight) LC50
--------------------------------------------------
small (3.88 cm, 0.96 g) 9500 mg/l
medium (6.09 cm, 2.80 g) 9500 mg/l
large (14.24 cm, 54.26 g) 11300 mg/l
--------------------------------------------------

Executive summary:

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 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

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.:

ca. 130 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % CL = 100-180

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 absence of mortality and abnormal effects after 96 hours of exposure was 56 mg/L.
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 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 1.0 × 10-4 mg/L and was within the 95 % confidence intervals reported in the literature.

Validity criteria fulfilled:

yes

Remarks:

Water quality parameters of temperature, dissolved oxygen and pH were measured throughout the test and were within acceptable limits.

Conclusions:

A test of the short-term toxicity of lactic acid (SY-83) to bluegill sunfish resulted in an LC50 of 130 mg/L (nominal).

Executive summary:

The acute toxicity of lactic acid (SY-83) to bluegill sunfish (Lepomis macrochirus) was assessed using the methods outlined by the Committee on Methods for Toxicity Tests with Aquatic Organisms. Water quality parameters of temperature, dissolved oxygen and pH were measured throughout the test and were within acceptable limits. As a method precision check, the bluegill sunfish were challenged with a reference compound, Antimycin A. The estimated 96 hour LC₅₀ and 95 % confidence limits (C.L.) were within the 95 % confidence limits reported in the literature. Culture and acclimation records indicated that the fish were in good condition for testing. The study was conducted at the following nominal concentrations of SY-83: 56, 100, 180, 320 and 560 mg/L. Ten fish, with a mean weight of 0.37 (± 0.15) g and a mean standard length of 24 (± 2.3) mm, were exposed to each test concentration and a blank control. The results of the four day static fish toxicity studies using lactic acid and Antimycin A are summarized below. The 24 and 48 hour LC50 values were also determined.

Lactic acid:

LC₅₀ (96 h) = 130 mg/L (95 % CI: 100–180 mg/L)

Antimycin A:

LC50 (96 h) = 1.0 × 10^–4 mg/L (95 % CI: 0.75–1.4 × 10^–4 mg/L)

Furthermore, the results indicate a 96-hour no-observed effect concentration of 56 mg/L, which was based on absence of mortality and abnormal effects.

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 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

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.:

>= 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/L 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-05 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/L under static conditions. The 96-h LC₅₀ was 130 mg/L. The NOEC value, based on mortality was 56 mg/L. Sublethal effects of surfacing and loss of equilibrium were 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 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) affected: Mortality, surfacing and loss of equilibrium.

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:

weight of evidence

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.:

ca. 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 species Brachydanio rerio was 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 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.

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:

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

Adequacy of study:

weight of evidence

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

Analytical monitoring:

yes

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4 630 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 = 4630 mg/L; 95 % CI =  3930–5360 mg/L

Sublethal observations / clinical signs:

The measured ion concentrations in the stock solution differed less than 20 % from nominal concentrations, 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 framework of analysing statistical models to predict the toxicity of major ions to Ceriodaphnia dubia, Daphnia manga and Pimephales promelas the toxicity of CaCl2 to aquatic invertebrates was assessed. The study was conducted according to U.S. EPA national methods. Thus, the study can be considered as reliable and in accordance with REACH requirements.

Executive summary:

In a 96-h acute toxicity study, fathead minnow (Pimephales promelas) were exposed to CaCl₂ at nominal concentrations of control, reference substance (NaCl), and test chemical at appropriate nominal concentrations under static conditions. The 96-h LC₅₀ was 4630 mg/L.  Based on the results of this study, CaCl₂ would not be classified as toxic to P. promelas in accordance with the CLP Regulation (EC) No 1272/2008.

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: 4630 mg/L (95 % C.I. = 3930–5360 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 6

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

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.:

10 650 mg/L

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

- Table: Results at 96 hours
-----------------------------------------------
CaCl2 (mg/l) pH Surv.(%)
-----------------------------------------------
6500 7.28 100
6500 7.44 100
8700 7.30 80
8700 7.39 80
10500 7.46 60
10500 7.42 60
10800 7.39 40
10800 7.33 40
12000 7.59 20
12000 7.60 10
-----------------------------------------------
- Water chemistry in test
Hardness (mg/l CaCO3) : 6314–11900
Alkalinity (mg/l CaCO3) : 32.6–49.6
Dissolved O2 (mg/l) : 7.2–8.7
pH : 7.19–7.80
Water hardness code : 4 -- Very hard (> 300 mg/l CaCO3)

Executive summary:

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 7

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

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.:

13 400 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

10 000 mg/L

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Table: Toxicity to Gambusia affinis
-----------------------------------------
Temp.(°C) 20-23
Turb.(ppm)
Init. 320
Final <25
pH Range 6.8-7.6
LC50 (mg/l)
24h 13400
48h 13400
96h 13400
-----------------------------------------

Executive summary:

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

Calcium (S)-lactate fully dissociates into Ca²⁺ ions and lactate when dissolved in water. The ecotoxicology of Calcium (S)-lactate can be understood in terms of the ecotoxicology of calcium 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 to exert any systemic effects on fish in the tested concentration range of up to 560 mg/L.

Several studies on acute toxicity of CaCl₂ to fish have been reported resulting in estimated LC₅₀ values ranging between 9,500 and 13,400 mg/L. Mount et al. (1997) published a peer-reviewed study on the toxicity of several ionic compositions, including CaCl₂, to Daphnia magna, Ceriodaphnia dubia, and Pimephales promelas. The test with P. promelas was conducted similar to the OECD test guideline 203. The determined 96-h LC50 was 4630 mg/L.

Overall, effect values describing the potential toxicity of Calcium (S)-lactate are far beyond the limits relevant for classification and labelling. Re-calculated to Calcium (S)-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. Calcium (S)-lactate is not hazardous for fish.