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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
The concentration of the test substance was determined in one representative test interval per week in each freshly prepared test solution (test vessels without daphnids) and in the 48h or 72h old test solutions before renewal (combined sample from test vessels with daphnids).
The stability of the test substance as a solution in test media and under testing conditions was determined by concentration control analysis.
Vehicle:
yes
Details on test solutions:
A stock test solution (10 mg/L) was prepared by dissolving 20 mg of test substance in 2L of test medium and stirring for approximately 10 min. The test solutions were prepared by dilution of a stock solution of the test substance in M4 medium.
Test organisms (species):
Daphnia magna
Details on test organisms:
The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978 and was then cultured at BASF.
Acclimatization: The Daphnia are cultured under the identical conditions as the test including test media (Elendt M4), water quality, temperature (20 ±1°C) and diet.
Age at test initiation: < 24 h
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
No
Hardness:
Total hardness: 2.20 – 3.20 mmol/L
Test temperature:
20 - 21 °C.
pH:
7.9 (Day 0) to 7.5-7.8 on Day 21.
Dissolved oxygen:
8.7 mg/L (Day 0) to 8.2-8.6 on Day 21.
Salinity:
/
Nominal and measured concentrations:
Nominal: 0-0.625-1.25-2.5-5.0-10.0 mg/L
Time-weighted mean: n.d.-0.666-1.375-2.627-5.550-11.02 mg/L
Details on test conditions:
Test medium: A synthetic fresh water (Elendt M4) is used as media for culture and test purposes. For the composition of this M4 medium see OECD 211. The general properties of this medium are as follows. Total hardness: 2.20 – 3.20 mmol/L. Acid capacity up to pH 4.3: 0.80 – 1.00 mmol/L. Molar ratio Ca:Mg: about 4 : 1. pH value: 7.5 – 8.5. Conductivity: 550 - 650 µS/cm. Total organic carbon: < 2 mg/L.
Dissolved oxygen: Must remain >=3mg/L during the test. To assure optimal dissolved oxygen levels, the M4 medium is aerated for approximately 24 h prior to use.
Test vessels: Glass beakers (100 mL), covered with glass.
Test volume: 50 mL.
Biological loading: 1 animal / test vessel.
Light intensity / Photo period: 662 – 721 lux at a wave length of 400 -750 nm. 16 hours light : 8 hours darkness
Aeration: none.
Test solution renewal: Semi-static, renewal 3 times per week.
Diet: During the test daphnids were fed daily a diet of live green algae Desmodesmus subspicatus, cultured in a synthetic medium. The daphnids were fed a defined volume (≤133 µL) of the concentrate to reach the amount of food of 0.1 increasing to 0.2 mg TOC/d.
Reference substance (positive control):
yes
Remarks:
periodically
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
For detailed results see the attachment "Results of the Daphnia reprotox study.docx".
Analytical results:
The analytically determined concentrations of the test substance in the test water were in a range of ±20% of the nominal concentration at start of the first interval in all tested concentrations. At the end of the first interval the analytically measured concentrations were slightly increased in test groups 1 (0.625 mg/L) and 3 (2.5 mg/L) to 125.6 and 126.2% of the nominal concentration respectively. The abiotic replicates from the first interval were within ±20% of the nominal concentrations. These samples were analyzed to assist in the interpretation of results in the event that food algae or Daphnia over the exposure period interfered with the test substance analyses.
However, all other measured concentrations were within a range of ±20% of the mean value determined for the whole exposure period. Therefore time-weighted mean measured concentrations were calculated and are considered to be an accurate representation of exposure levels throughout the exposure period.

Biological results:
Mortality was observed in the 1.25 and 10 mg/L treatment group, however it was not statistically significant and did not follow a concentration response pattern (negative Cochran-Armitage test). The observed mortalities were considered inadvertent and not related to the test substance. The reproduction endpoint is based on offspring per surviving adult, since there was no concentration response pattern to the mortality.
No additional adverse effects or abnormal behavior were observed in any of the test groups.




Results with reference substance (positive control):
The EC50(48 h) of the reference substance sodium chloride (NaCl) was 5.65 g/L (experiment date: 14 Oct 2014). This result is within the range of 3.88 – 7.22 g/L, which represents ±2 standard deviations from the published EC50(48 h) of 5.55 g/L and indicates that the culture of Daphnia magna used in this study is responding normally to toxic stress.
Reported statistics and error estimates:
No significant mortality, reduced reproduction or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments. The data were not sufficient to calculate ECx values for reproduction or mortality.
Since the measured concentrations deviated slightly from the nominal concentrations, the effect concentration, which is based on the time-weighted mean measured concentration should be preferably used for the evaluation of the test substance.

The water pH, temperature and dissolved oxygen were within acceptable guideline specifications.

All test solutions were visibly colorless and clear throughout each renewal period. No undissolved test substance or other unusual manifestations were observed.

Validity criteria fulfilled:
yes
Conclusions:
NOEC: >=11.0 mg/L
Executive summary:

In a 21-day chronic toxicity study, Daphnia magna were exposed to melamine at nominal concentrations of 0 (control), 0.625, 1.25, 2.5, 5.0, 10 mg/L and time-weighted mean measured concentrations of 0 (control), 0.666, 1.38, 2.63, 5.55, 11.0 mg/L under static renewal conditions in accordance with the OECD 211 guideline. The water pH, temperature and dissolved oxygen were within acceptable guideline specifications. Mortality, reproduction and sublethal effects were observed daily.

The following overall effect concentrations (mg/L) are based on reproduction (living offspring per surviving adult) as the primary population relevant response and were obtained based on time-weighted mean measured concentrations:

NOEC: >=11.0 mg/L

LOEC: >11.0 mg/L

No significant mortality, reduced reproduction or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments.

The results in this study are consistent with all validity criteria and the test is valid according to the guidelines of this study.

Description of key information

The chronic toxicity and the reproduction toxicity of melamine to Daphnia magna is low.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
11 mg/L

Additional information

The recent key study was performed according to the OECD211 method with Daphnia magna. The NOEC >=11 mg/L based on reproduction and other effects.

A further rather old study, but with a method similar to the present one, was performed.

The NOEC 21d for reproduction and mortality was found to be 18 mg/L.

The LC50 7d and 21d were estimated to be >32 mg/L and <56 mg/L.