N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study conducted in compliance with GLP regulations. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

See read across justification document in chapter 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm (RC, SCHLEICHER & SCHUELL).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age at study initiation: 2 - 24 h old
- Method of breeding: In 2-3 L glass vessels with approximatively 1.8 L culture medium, at 21 °C (temperatures of 20 - 25 °C are tolerated), in an
incubator, 16 h illumination, illumination strength max. 20 μmol photons⋅m-² ⋅s exp-1.
- Feeding: At least 5x weekly ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris,
with an algae cell density of > 10 exp6 cells/mL.
- Feeding during test: The daphnids were not fed during the study.

ACCLIMATION
- Acclimation period: ca. 2 h in dilution water

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

18 - 22 °C, ± 1 °C constant

pH:

7.86 test initial
7.81 - 7.85 end of test

Dissolved oxygen:

8.38 mg/L test initial
8.15 - 8.28 mg/L end of test

Nominal and measured concentrations:

Test concentration (nominal): 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm ID x 8 cm H), 50 mL volume
- Material: The solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application.
- Fill volume: 20 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: According to EC 92/69 L383A C.2. Annex

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity:Diffuse light, illumination range max. 20 μmol photons⋅m-² ⋅ s exp-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilisation of test organism

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: No acute toxicity within the range of solubility.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks on result:

other: No acute toxic effects within the range of solubility.

Results with reference substance (positive control):

24 hours - EC50 (potassium dichromate) : 2.07 mg/L, (CL 1.68 - 2.56)

Validity criteria fulfilled:

yes

Conclusions:

No acute toxic effects occurred within the range of solubility. The test substance is with high probability acutely not harmful to aquatic invertebrates.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

2004- 11-23 to 2004-11-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study conducted in compliance with GLP regulations. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

See read across justification document in chapter 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility < 1 mg/L
- pH value 7 (20 °C, 100 g/L)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm (RC, SCHLEICHER & SCHUELL).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age at study initiation: 2 - 24 h old
- Method of breeding: In 2-3 L glass vessels with approximatively 1.8 L culture medium, at 21 °C (temperatures of 20 - 25 °C are tolerated), in an
incubator, 16 h illumination, illumination strength max. 20 μmol photons⋅m-² ⋅s exp-1.
- Feeding: At least 5x weekly ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 10 exp6 cells/mL.
- Feeding during test: The daphnids were not fed during the study.


ACCLIMATION
- Acclimation period: ca. 2 h in dilution water

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

18 - 22 °C, ± 1 °C constant

pH:

7.85 test initial
7.83 - 7.85 end of test

Dissolved oxygen:

8.28 mg/L initial test
8.20 - 8.35 mg/L end of test

Nominal and measured concentrations:

Test concentration (nominal): 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm ID x 8 cm H), 50 mL volume
- Material: The solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application.
- Fill volume: 20 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: According to EC 92/69 L383A C.2. Annex

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity:Diffuse light, illumination range max. 20 μmol photons⋅m-² ⋅ s exp-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilisation of test organism

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: No acute toxic effects within the range of solubility.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks on result:

other: No acute toxic effects within the range of solubility.

Results with reference substance (positive control):

24 hours - EC50 (potassium dichromate) : 2.07 mg/L, (CI 1.68 - 2.56)

Validity criteria fulfilled:

yes

Conclusions:

No acute toxic effects occurred within the range of solubility. The test substance is with high probability acutely not harmful to aquatic invertebrates.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2004- 11-23 to 2004-11-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study conducted in compliance with GLP regulations. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility < 1 mg/L
- pH value 7 (20 °C, 100 g/L)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm (RC, SCHLEICHER & SCHUELL).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age at study initiation: 2 - 24 h old
- Method of breeding: In 2-3 L glass vessels with approximatively 1.8 L culture medium, at 21 °C (temperatures of 20 - 25 °C are tolerated), in an
incubator, 16 h illumination, illumination strength max. 20 μmol photons⋅m-² ⋅s exp-1.
- Feeding: At least 5x weekly ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 10 exp6 cells/mL.
- Feeding during test: The daphnids were not fed during the study.


ACCLIMATION
- Acclimation period: ca. 2 h in dilution water

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

18 - 22 °C, ± 1 °C constant

pH:

7.85 test initial
7.83 - 7.85 end of test

Dissolved oxygen:

8.28 mg/L initial test
8.20 - 8.35 mg/L end of test

Nominal and measured concentrations:

Test concentration (nominal): 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm ID x 8 cm H), 50 mL volume
- Material: The solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application.
- Fill volume: 20 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: According to EC 92/69 L383A C.2. Annex

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity:Diffuse light, illumination range max. 20 μmol photons⋅m-² ⋅ s exp-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilisation of test organism

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: No acute toxic effects within the range of solubility.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks on result:

other: No acute toxic effects within the range of solubility.

Results with reference substance (positive control):

24 hours - EC50 (potassium dichromate) : 2.07 mg/L, (CI 1.68 - 2.56)

Validity criteria fulfilled:

yes

Conclusions:

No acute toxic effects occurred within the range of solubility. The test substance is with high probability acutely not harmful to aquatic invertebrates.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study conducted in compliance with GLP regulations. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The stock solution was shaken at room temperature with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45 μm (RC, SCHLEICHER & SCHUELL).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu)
- Age at study initiation: 2 - 24 h old
- Method of breeding: In 2-3 L glass vessels with approximatively 1.8 L culture medium, at 21 °C (temperatures of 20 - 25 °C are tolerated), in an
incubator, 16 h illumination, illumination strength max. 20 μmol photons⋅m-² ⋅s exp-1.
- Feeding: At least 5x weekly ad libitum with a mix of Desmodesmus subspicatus and Chlorella vulgaris,
with an algae cell density of > 10 exp6 cells/mL.
- Feeding during test: The daphnids were not fed during the study.

ACCLIMATION
- Acclimation period: ca. 2 h in dilution water

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

18 - 22 °C, ± 1 °C constant

pH:

7.86 test initial
7.81 - 7.85 end of test

Dissolved oxygen:

8.38 mg/L test initial
8.15 - 8.28 mg/L end of test

Nominal and measured concentrations:

Test concentration (nominal): 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm ID x 8 cm H), 50 mL volume
- Material: The solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application.
- Fill volume: 20 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: According to EC 92/69 L383A C.2. Annex

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity:Diffuse light, illumination range max. 20 μmol photons⋅m-² ⋅ s exp-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilisation of test organism

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: No acute toxicity within the range of solubility.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks on result:

other: No acute toxic effects within the range of solubility.

Results with reference substance (positive control):

24 hours - EC50 (potassium dichromate) : 2.07 mg/L, (CL 1.68 - 2.56)

Validity criteria fulfilled:

yes

Conclusions:

No acute toxic effects occurred within the range of solubility. The test substance is with high probability acutely not harmful to aquatic invertebrates.

Description of key information

Red disazo condensation pigments are with high probability acutely not harmful to aquatic invertebrates. 
No toxic effects occur at the range of the substances solubility.
EC50 (48h) > 100 mg/L (nominal) for Daphnia magna (OECD 202)

Additional information

The acute toxicity on aquatic invertebrates was investigated for two ‘red disazo condensation pigments’(CAS 40618-31-3 and CAS 52238-92-3) with the waterflea Daphnia magna, in GLP guideline studies according to OECD 202 [DR.U.NOACK-LABORATORIEN, 2004]. Based on the low water solubility of the test item, saturated stock solutions were prepared and the tests were conducted as limit tests with a nominal concentration of 100 mg/L. For both substances no effects on the swimming mobility of daphnia within the range of solubility are observed after 48 hours of exposure.