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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
Study period:
55 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
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
Specific details on test material used for the study:
Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99%.
Analytical monitoring:
yes
Details on sampling:
Readings taken every 24 hours for 48 hours
Vehicle:
no
Remarks:
Material insoluble in water
Details on test solutions:
The batch of Disperse Blue 359 tested was a dark blue powder with a purity of 99% and not completely soluble in test medium at the loading rate initially prepared. No correction was made for the purity/composition of the test item.

Preparation of test solutions started with a loading rate of 100 mg/L applying a three-day period of magnetic stirring to accelerate dissolution of the test item in medium. The obtained mixture was filtered through a 0.45 μm membrane filter (RC55, Whatman) and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Four replicates for each dose group, 0, 1, 10 and 100% of a 100 mg/L Disperse Blue 359 saturated solution.
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
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
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)
Results with reference substance (positive control):
The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations (i.e., the 48h-EC50 was between 0.3 and 1.0 mg/L). Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at Charles River Den Bosch.

The 24h-EC50 was 0.64 mg/L with a 95% confidence interval between 0.56 and 0.73 mg/L.
The 48h-EC50 was 0.48 mg/L with a 95% confidence interval between 0.43 and 0.53 mg/L.
The raw data from this study are kept in the Charles River Den Bosch archives. The test described above was performed under GLP with a QA-check.
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).