Malonic acid

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Succinic acid may be used as an analogue for malonic acid, based on the following considerations. Firstly, dicarboxylic acids are naturally occurring metabolic products of fatty acid oxidation, and are rapidly beta-oxidised. A category approach for short-medium chain dicarboxylic acids, including malonic acid and succinic acid, has been validated and used by various bodies including the Cosmetics Ingredient Review Panel and the European Food Safety Authority.Disodium succinate may be used as an analogue for succinic acid as there is no significant difference in toxicity expected between succinic acid and disodium succinate, since both substances will dissociate into succinate ion under physiological conditions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

Disodium succinate hexahydrate (CAS No.: 6106-21-4, Nacalai Tesque, Inc. (Japan), Lot. No.: MOT9476, Purity = 100.2%, Molecular Weight = 270.14

Analytical monitoring:

yes

Details on sampling:

Analytical Procedure: The tested concentrations were measured at the start and the end of the test period using HPLC.

Vehicle:

no

Details on test solutions:

Vehicle/Solvent and Concentrations: Any solvent was not used.Stock Solutions Preparations and Stability: Test chemical was refrigerated. The stability of the chemical was confirmed by IR spectrum.The IR spectrum at the end of the test was same at the start of test. Dilution Water Source: Dilution water was prepared from tap water (Kurume city, Japan). The tap water was dechlorinated and treated by ctivated carbon. After that Residual Chlorine was removed from the water. Before using the dilution water, aeration was fully carried out.

Test organisms (species):

Oryzias latipes

Details on test organisms:

Supplier: Test organisms were obtained from Nakajima Yougyo-jo (Private Fish Farm, Japan), before one month and a half of a test.Size (length and weight): 2.3 cm (2.2 - 2.4 cm) in length; 0.16 g (0.13 - 0.23 g) in weightAge: Not describedTest organisms were acclimated for 28 days before testing. During acclimation, test fishes were fed with TETRAMINE equivalent to 3% of weight per day. These test organisms were not fed for 24 hours before the test started. The mortality of the test organisms for 7 days before testing was less than 5%.

Test type:

flow-through

Water media type:

freshwater

Hardness:

Total hardness (as CaCO3): = 61.0 mg/L

Test temperature:

Water temperature were measured for old and renewal solution with control and each concentration at the start of test and every 24 hours.Water Temperature: 24.1 - 24.9ºC

pH:

Water chemistrywas measured for old and renewal solution with control and each concentration at the start of test and every 24 hours.pH: 7.6 - 7.8Water Temperature: 24.1 - 24.9ºC

Dissolved oxygen:

Water chemistrywas measured for old and renewal solution with control and each concentration at the start of test and every 24 hours.DO: 7.5 - 8.3 mg/L

Nominal and measured concentrations:

Nominal Concentrations: control, 6.25, 12.5, 25.0, 50.0 and 100 mg/L

Details on test conditions:

Light Condition: 16:8 hours, light-darkness cycleFeeding: NoneAeration : Test solution was not aerated during the test period.

Reference substance (positive control):

yes

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 95.4 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

47 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 95.4 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

None of the test organisms were killed during exposure period at control, 6.25, 12.5, 25.0, 50.0 mg/L. The lowest concentration from which the test organisms were killed was 100mg/L at 96 h.Other Effect: Toxicological symptoms were not observed at any concentration.

Results with reference substance (positive control):

LC50(96 hr) for a reference substance (copper sulfate pentahydrate) was 0.707 mg/L.

Reported statistics and error estimates:

Data Analysis: During test period the test organismss motality was less than 50% in all concentrations, therefore the LC50 is more than the highestconcentration.Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): Arithmetic mean

Sublethal observations / clinical signs:

Cumulative Mortality

Measured Conc. mg/L	Cumulative Number of Dead (Percent Mortality)
	24hr	48hr	72hr	96hr
Control	0 (0)	0 (0)	0 (0)	0 (0)
5.64	0 (0)	0 (0)	0 (0)	0 (0)
11.6	0 (0)	0 (0)	0 (0)	0 (0)
23.6	0 (0)	0 (0)	0 (0)	0 (0)
47.0	0 (0)	0 (0)	0 (0)	0 (0)
95.4	0 (0)	0 (0)	0 (0)	1 (10)

 

Measured Concentrations: The tested concentrations were measured at 0 and 96 hour. For all of them, the deviations from the nominal concentration were less than +/-20%.

Nominal conc. mg/L	Measured Conc., mg/L		Mean* mg/L	Percent of nominal
	0 Hour	96 Hour		0 Hour	96 Hour
Control	<0.600	<0.600	---	---	---
6.25	6.14	5.13	5.64	98.2	82.1
12.5	12.2	10.9	11.6	97.6	87.4
25.0	24.3	22.8	23.6	97.3	91.3
50.0	46.6	47.3	47.0	93.2	94.6
100	94.8	96.1	95.4	94.8	96.1

*: Mean measured concentration (Arithmetic mean)

Validity criteria fulfilled:

yes

Conclusions:

In a 96 h acute toxicity study of disodium succinate hexahydrate with fish (OECD TG 203, Oryzias latipes, flow-through), the study recorded a 96 h LC0 of 47.0 mg/L (equivalent to 28.2 mg/L disodium succinate), 96 h LC50 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate) and 96 h LC100 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate). In this test, only one individual out of twenty died at the highest concentration of 95.4 mg/L.

Executive summary:

In a 96 h acute toxicity study of disodium succinate hexahydrate with fish (OECD TG 203, Oryzias latipes, flow-through), the study recorded a 96 h LC0 of 47.0 mg/L (equivalent to 28.2 mg/L disodium succinate), 96 h LC50 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate) and 96 h LC100 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate).. In this test, only one individual out of twenty died at the highest concentration of 95.4 mg/L.

Description of key information

In a 96 h acute toxicity study of disodium succinate hexahydrate with fish (OECD TG 203, Oryzias latipes, flow-through), the study recorded a 96 h LC0 of 47.0 mg/L (equivalent to 28.2 mg/L disodium succinate), 96 h LC50 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate) and 96 h LC100 > 95.4 mg/L (equivalent to 57.2 mg/L disodium succinate).. In this test, only one individual out of twenty died at the highest concentration of 95.4 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

57.2 mg/L