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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
>10% daphnids were immobilized/trapped at the surface of the control solution in the combined limit/range-finding test. In simultaneously performed tests no effects were observed in the control treatment, accept the results and use as a range-finder.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Readings taken every 24 hours for 48 hours
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna (Crustacea, Cladocera) (Straus 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions. Tests ran with new born daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
Test type:
static
Water media type:
not specified
Limit test:
yes
Total exposure duration:
48 h
Hardness:
180 mg/L expressed as CaCO3
Test temperature:
18-22 °C
pH:
7.7 ± 0.3
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 2.6 µg/L
Nominal / measured:
not specified
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Remarks on result:
not determinable
Remarks:
The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6 µg/L)
Details on results:
The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6 µg/L)
Validity criteria fulfilled:
yes
Conclusions:

A limit test was performed based on the results of a combined limit/range-finding test. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an intreated control and to a saturated solution prepared at a loading rate of 100 mg/L. The total exposure period was 48 hours and samples or analytical confirmation of exposure concentrations were taken at the start and end of the test.
Samples taken from the limit concentration were analysed. The actual concentrations were below the LOD of the analytical method (LOD=5.1 µg/L) from the beginning of the exposure. Therefore, the effect parameters were expressed in terms of solubility in test medium, i.e. 2/6 µg/L (i.e. half of the LOD).
The study met the acceptability criteria prescribed by the study plan and was considered valid. The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6 µg/L).
Executive summary:

 

A limit test was performed based on the results of a combined limit/range-finding test. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an intreated control and to a saturated solution prepared at a loading rate of 100 mg/L. The total exposure period was 48 hours and samples or analytical confirmation of exposure concentrations were taken at the start and end of the test.

Samples taken from the limit concentration were analysed. The actual concentrations were below the LOD of the analytical method (LOD=5.1µg/L) from the beginning of the exposure. Therefore, the effect parameters were expressed in terms of solubility in test medium, i.e. 2/6µg/L (i.e. half of the LOD).

The study met the acceptability criteria prescribed by the study plan and was considered valid. The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6µg/L).

Description of key information

 

A limit test was performed based on the results of a combined limit/range-finding test. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an intreated control and to a saturated solution prepared at a loading rate of 100 mg/L. The total exposure period was 48 hours and samples or analytical confirmation of exposure concentrations were taken at the start and end of the test.

Samples taken from the limit concentration were analysed. The actual concentrations were below the LOD of the analytical method (LOD=5.1µg/L) from the beginning of the exposure. Therefore, the effect parameters were expressed in terms of solubility in test medium, i.e. 2/6µg/L (i.e. half of the LOD).

The study met the acceptability criteria prescribed by the study plan and was considered valid. The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6µg/L).

Key value for chemical safety assessment

Additional information

 

A limit test was performed based on the results of a combined limit/range-finding test. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an intreated control and to a saturated solution prepared at a loading rate of 100 mg/L. The total exposure period was 48 hours and samples or analytical confirmation of exposure concentrations were taken at the start and end of the test.

Samples taken from the limit concentration were analysed. The actual concentrations were below the LOD of the analytical method (LOD=5.1µg/L) from the beginning of the exposure. Therefore, the effect parameters were expressed in terms of solubility in test medium, i.e. 2/6µg/L (i.e. half of the LOD).

The study met the acceptability criteria prescribed by the study plan and was considered valid. The 48h-EC50 was beyond range tested, i.e. exceeded the maximum solubility of Disperse Blue 359 in test medium (> 2.6µg/L).