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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Sampling and analysis

Analytical monitoring:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d

Results and discussion

Effect concentrations
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 35 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
immobilisation
Remarks on result:
other: NOEC is higher than the water solubility

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item C.I. Pigment Red 3 had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the highest test concentration of mean measured 35 μg/L (nominal 45 μg/L). This test concentration is clearly above the water solubility of the test item. The 21-day NOEC of the test item was determined to be at least 35 μg/L. The 21-day LOEC was above the highest test concentration of 35 μg/L.Thus, the test item C.I. Pigment Red 3 had no toxic effects on Daphnia magna at least up to its solubility limit in test water.The 21 day EC50 for the inhibition of the reproduction rate of the daphnids could not be calculated due to the absence of toxic effect up to the highest test concentration, but was determined to be >35 μg/L
Executive summary:

The effect of the test item C.I. Pigment Red 3 on the survival, and reproduction ofDaphnia magnawas investigated in a semi-static test over 21 days following the OECD Guidelines for Testing of Chemicals, No. 211 (2008): “Daphnia magnaReproduction Test”, the EU Commission Directive 92/69/, C.20: “Daphnia magnaReproduction Test” and the Commission Regulation (EC) No 440/2008, C.20: “Daphnia magna Reproduction Test”.

 The nominal concentrations tested were 0.45, 1.4, 4.5, 14, and 45 μg/L. Additionally, a control and a solvent control were tested in parallel.

The preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000).

The concentration of the test item measured in freshly prepared test medium of the nominal test concentrations of 45 μg/L was between 93 and 101 % of the nominal value. This shows the correct dosage of the test item. At the end of the renewal periods, 50 to 80 % of nominal were found in the samples with and without food.

For the nominal test concentration of 45 μg/L, the mean measured test item concentration was calculated as thetime-weighted meansover all measurements. Thereby, samples from the actual test (with food) were taken into account.

The biological results are based onthe mean measured test item concentration of 35 μg/L. This measured concentration is clearly above the water solubility of the test item as provided by the sponsor.

The test item C.I. Pigment Red 3 had no toxic effects on survival and reproduction of Daphnia magna after the exposure period of 21 days up to the highest test concentration of mean measured 35 μg/L (nominal 45 μg/L). This test concentration is clearly above the water solubility of the test item. The 21-day NOEC of the test item was determined to be at least 35 μg/L. The 21-day LOEC was above the highest test concentration of 35 μg/L.

 Thus, the test item C.I. Pigment Red 3 had no toxic effects on Daphnia magna at least up to its solubility limit in test water.

 

The 21‑day EC50for the inhibition of the reproduction rate of the daphnids could not be calculated due to the absence of toxic effect up to the highest test concentration, but was determined to be >35 μg/L