Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Year 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant 21-day reproduction study performed by the Japanese Ministry of the Environment as part of its contribution to the ellaboration of the OECD HPV SIDS report on analogue disodium succinate.
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Disodium succinate (anhydrous) has the following physical properties: boil.p and melt.p.: > 400 °C; solubility in water:> 100 g/L; vapour preseere: < 0,00015 at 100 °C; log Kow: < 0.59 (estimated); pKas: (1) 4,21; (2) 5,64 (for succinic acid).
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
Dilution water was prepared from tap water (Kurume city, Japan). The tap water was dechlorinated and treated by activated carbon. After that Residual Chlorine was removed from the water. No solvent other than dilution water was used. Test chemical wasrefrigerated. 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.
Test organisms (species):
Daphnia magna
Details on test organisms:
Age: < 24 hours old
Supplier/Source: Test organisms were obtained from the University of Sheffield (UK) and had been reproduced in the testing laboratory for 10
years.
Pretreatment: Parental daphnids were acclimated for 38 days on test conditions before testing, any groups showing high mortality were not
used for testing. The mortality of the daphnids was less than 5% for 2 weeks before testing.
EC50(48 hr, immobility) for a reference substance (potassium dichromate) was 0.171mg/L.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
61.0 mg/L CaCO3
Test temperature:
20.1 - 20.6 throughout the test
pH:
7.6 - 7.8 throughout the test
Dissolved oxygen:
7.7 - 8.9 throughout the test
Nominal and measured concentrations:
Nominal: control,25.0; 50.0; and 100.0 mg/L (as anhydrous disodium succinate)
Measured (time weighted average): 0, 19.1; 45.2; 95.2 mg/L
Details on test conditions:
a) Dilution Water Source: Dilution water was prepared from tap water (Kurume city, Japan). The tap water was dechlorinated and treated by
activated carbon. After that Residual Chlorine was removed from the water.
b) Dilution Water Chemistry: pH: = 7.4
Total hardness (as CaCO3): = 61.0 mg/L

c) Exposure Vessel Type: 80 mL test solution in a glass beaker
d) Nominal Concentrations: control, solvent control, 25.0, 50.0 and 100 mg/L
e) Vehicle/Solvent and Concentrations: Any solvent was not used.
f) 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.
g) Number of Replicates: 10
h) Individuals per Replicates: 10
i) Renewal Rate of Test Water: once per day
j) Water Temperature: 20+/-1 °C
k) Light Condition: 16:8 hours, light-darkness
l) Feeding: 0.1 - 0.2 mg carbon/day/individual (Chlorella vulgaris: Green algae)
m) Aeration: not described
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
> 95.2 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 95.2 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
95.2 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
Effect: reproduction- Measured Concentrations: The test concentrations were measured for both renewal and old test solution at the start of test
and 1st, 8th, 9th, 16th and 17th day. Some of them, the deviation from the nominal concentration were not less than +/-20%.
Cumulative Number of Died Parental Daphnids: No test organism was killed at control solvent control, 0.13, 0.24 and 0.38 mg/L. The lowest concentration that test organisms were dead was at 25.0 mg/L after 10days.
Effect Data(reproduction):Juveniles were first produced on the 8th day at every concentration.
Results with reference substance (positive control):
EC50(48 hr, immobility) for a reference substance (potassium dichromate) was 0.171mg/L.
Reported statistics and error estimates:
LC50 and EC50: During test period the test organisms were not killed in more than 50% at any concentration. The effects on reproduction were
less than 50%. Due to this reason LC50 and EC50 is greater than than the highest concentration tested.
NOEC and LOEC: The cumulative number of juveniles produced per adult in control and test vessels after 21days was tested by Bartlett's test
and one-way analysis of variance. The cumulative number of dead
parental daphnids after 21 days was tested by Kruskal-Wallis test. NOEC and LOEC were determined by these results and juvenile and parental
daphnids condition of activity.
b) Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): Time-weighted Mean

NOEC was determined based on the cumulative number of alive juveniles produced per adult alive.

Se image below.

Validity criteria fulfilled:
yes
Conclusions:
No significant mortality of reproductive effect was detected upon parental daphnids exposed to a maximum measured concentration of 95.2 mg/L of disodium succinate (anhydrous) for a period of 21 days. EC50 is determined as > 95.2 mg/L and NOEC is determined as 95.2 mg/L. Given that potassium sodium tartrate is a structurally very similar the C4 dicarboxyllic acid salt tested the result is considered as very relevant towards read-across.
Executive summary:

No significant mortality of reproductive effect was detected upon parental daphnids exposed to a maximum measured concentration of 95.2 mg/L of disodium succinate (anhydrous) for a period of 21 days. EC50 is determined as > 95.2 mg/L and NOEC is determined as 95.2 mg/L. Given that potassium sodium tartrate is a structurally very similar the C4 dicarboxyllic acid salt tested the result is considered as very relevant towards read-across.

Description of key information

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
95.2 mg/L

Additional information

No significant mortality of reproductive effect was detected upon parental daphnids exposed to a maximum measured concentration of

95.2 mg/L of disodium succinate (anhydrous) for a period of 21 days. EC50 is determined as > 95.2 mg/L and NOEC is determined as

95.2 mg/L. Given that potassium sodium tartrate is a structurally very similar the C4 dicarboxyllic acid salt tested the result is considered

as very relevant towards read-across.