Registration Dossier

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25.05.2012 - 28.08.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
- Elendt M7 medium solvent for the test item
- The test item is soluble only in concentrated sulfuric acid
- The solubility limit of the test item is 91 μg/L (i.e. 0.091 mg/L) in water. After sonication, heating and shaking the powder test item in the test medium is visually a heterogeneous suspension.
- The mixture of 10 mg/L was prepared by weighing the powder test item and transferring it into a flask by multiple washing with test medium. The mixture was sonicated for 15 min at 40°C.
- The mixture was heated and shaken at 68-70°C for 2 h (in incubator [SOP/W/75]) and then shaken at room temperature for 72 h [SOP/W/57].
- The non-dissolved part of the test concentration was separated by filtration. A sequential filtration was performed to ensure complete removal of particles from the test solution: once through 0.45 μm, once through 0.2 μm and twice through 0.025 μm pre-conditioned nitrocellulose membrane filters.
- The filtrate after the three filtration steps is the Water Accommodated Fraction (WAF) used for exposure.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Source: Institute of Industrial Organic Chemistry Branch Pszczyna, Department of Ecotoxicology, Laboratory of Aquatic Toxicology
- Age of parental stock: < 24 h old
- Feeding during test: yes
- Food type: algal suspension Pseudokirchneriella subcapitata
- Amount: supplying ~ 0.2 mg organic carbon per parent Daphnia
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
185.0 - 228.6 mg CaCO3/L
Test temperature:
20.3 – 23.1 ºC
pH:
7.55 - 8.28
Dissolved oxygen:
7.70 - 8.72%
Nominal and measured concentrations:
Nominal test concentrations: control and 10 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Size, fill volume: 150 ml, 50 ml
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): complete renewal three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Conductivity: 564 - 583 μS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h darkness
- Light intensity: 609 - 741 lx

Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No toxic effects within the range of solubility.
Details on results:
Based on number of alive offspring, immobilization and growth (body length) of parent daphnids.

- mortality of the parent animals in the control was 0% (should not exceed 20% at test termination)

- the mean number of live offspring produced per parent animal surviving at test termination in the control was 111.3 (should be higher or equal to 60)

Validity criteria fulfilled:
yes
Conclusions:
The test substance is with high probability chronically not harmful to aquatic invertebrates. No toxic effects occur at the range of the substances solubility.
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
25.05.2012 - 28.08.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
see Rationale and Justification for the Analogue Read-Across Approach used for the Registration of Pigment Brown 41 (Chapter 13)
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
- Elendt M7 medium solvent for the test item
- The test item is soluble only in concentrated sulfuric acid
- The solubility limit of the test item is 91 μg/L (i.e. 0.091 mg/L) in water. After sonication, heating and shaking the powder test item in the test medium is visually a heterogeneous suspension.
- The mixture of 10 mg/L was prepared by weighing the powder test item and transferring it into a flask by multiple washing with test medium. The mixture was sonicated for 15 min at 40°C.
- The mixture was heated and shaken at 68-70°C for 2 h (in incubator [SOP/W/75]) and then shaken at room temperature for 72 h [SOP/W/57].
- The non-dissolved part of the test concentration was separated by filtration. A sequential filtration was performed to ensure complete removal of particles from the test solution: once through 0.45 μm, once through 0.2 μm and twice through 0.025 μm pre-conditioned nitrocellulose membrane filters.
- The filtrate after the three filtration steps is the Water Accommodated Fraction (WAF) used for exposure.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Source: Institute of Industrial Organic Chemistry Branch Pszczyna, Department of Ecotoxicology, Laboratory of Aquatic Toxicology
- Age of parental stock: < 24 h old
- Feeding during test: yes
- Food type: algal suspension Pseudokirchneriella subcapitata
- Amount: supplying ~ 0.2 mg organic carbon per parent Daphnia
- Frequency: daily
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
185.0 - 228.6 mg CaCO3/L
Test temperature:
20.3 – 23.1 ºC
pH:
7.55 - 8.28
Dissolved oxygen:
7.70 - 8.72%
Nominal and measured concentrations:
Nominal test concentrations: control and 10 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Size, fill volume: 150 ml, 50 ml
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): complete renewal three times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Conductivity: 564 - 583 μS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h darkness
- Light intensity: 609 - 741 lx

Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No toxic effects within the range of solubility.
Details on results:
Based on number of alive offspring, immobilization and growth (body length) of parent daphnids.

- mortality of the parent animals in the control was 0% (should not exceed 20% at test termination)

- the mean number of live offspring produced per parent animal surviving at test termination in the control was 111.3 (should be higher or equal to 60)

Validity criteria fulfilled:
yes
Conclusions:
The test substance is with high probability chronically not harmful to aquatic invertebrates. No toxic effects occur at the range of the substances solubility.

Description of key information

The substance is with high probability chronically not harmful to aquatic invertebrates.
No toxic effects occur at the range of the substance solubility.
NOEC (21d) >= 10 mg/L (nominal) for Daphnia magna reproduction (OECD 211)

Key value for chemical safety assessment

Additional information

The long-term aquatic toxicity was investigated in a GLP guideline study according to OECD 211 for one ‘red disazo condensation pigment’ (PR221) [lnstitute of lndustrial Organic Chemistry, Branch Pszczyna, 2012]. The waterfleas (Daphnia magna) were exposed under semi-static conditions to 10 mg/L substance (nominal). Based on reproduction and mortality no effects observed during the 21 days of test duration.