N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]

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:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

only 24 hour evaluations were performed; the highest vehicle concentraton was 147.7 mg/L

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

yes

Remarks:

alkylphenol-polyglykol-ether

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 4.0 g TK 10015 and 40 mg alkylphenol-polyglykol-ether were mixed with and made up to 10 mL with DMF. This solution was diluted to 100 mg/L with water.
with water.
- Controls: water and vehicle
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): alkylphenol-polyglykol-ether
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 146.7 mg DMF and 1 mg alkylphenol-polyglykol-ether per liter water in the concentration used for the highest test concentration was used as vehicle control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Small parts of the test substance were swimming at the surface of the test solutions at concentration of 10-100 mg/L (nominal) from the start of the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna Straus 1820
- Source: CIBA-GEIGY Ltd., Facilities, Basle
- Age of parental stock (mean and range, SD): (0-24h
- Feeding during test: None

ACCLIMATION
- Type and amount of food: suspension of green algae (Scenedesmus subspicatus) supplemented by a suspension of TETRAMIN-extract in such quantities that the food is consumed after 24h
- Feeding frequency: three times weekly

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Hardness:

240 mg CaC03/L

Test temperature:

20±1°C

pH:

0-hour: 8.1-8.2
24-hour: 8.0-8.2

Dissolved oxygen:

0-hour: 96-98%
24-hour: 101-103%

Nominal and measured concentrations:

Nominal: 10, 18, 32, 58, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers covered with watch glasses
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 mL solution/beaker
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light, 16 hours daily
- Light intensity: approx. 2000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility

VEHICLE CONTROL PERFORMED: yes

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

82 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobility

Remarks on result:

other: 95% confidence limits

Remarks:

69-108 mg/L

Details on results:

Immobilization was 0, 0, 0, 0, 0, 25, and 65% at 0 (blank), 0 (vehicle), 10, 18, 32, 58, and 100 mg/L.

Reported statistics and error estimates:

The EC-50 values were calculated according to BERKSON, JASA 48 (1953), 569-599. EC-values were graphically determined on gausso-logarithmic probability paper.

Conclusions:

24-hour EC50 (Daphnia magna): 82 mg/L

Executive summary:

The ability of the test substance to cause effects to Daphnia magna was examined in a test in accordance with OECD guideline 202. Twenty Daphnia (4 replicates of 5 Daphnia each) per concentration and control were exposed to nominal concentrations of 10, 18, 32, 58, and 100 mg/L. The 24-hour EC50 was 82 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Justification for type of information:

Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: Official Journal of the European Communities L 251,vol.27,C-02,19/09/1984.

Deviations:

yes

Remarks:

No evidence that test concentrations were maintained during exposure.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 200.3 mg test substance were mixed with and made up to 2000 ml
with test water. Calculated amounts of the stock solution to produce the desired test concentrations were given into the water and were homogeneously distributed.
- Controls: blank (water)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): At 3.2 to 100 mg/L small parts of the test substance were swimming at the surface of the test vessels at all test times.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna Straus 1820
- Source: CIBA-GEIGY Ltd., Facilities, Basle
- Age of parental stock (mean and range, SD): (6-24h)
- Feeding during test: None

ACCLIMATION
- Type and amount of food: suspension of green algae (Scenedesmus subspicatus) supplemented by a suspension of TETRAMIN-extract in such quantities that the food is consumed after 24h
- Feeding frequency: three times weekly

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Hardness:

240 mg CaC03/L

Test temperature:

20±1°C

pH:

0-hour: 8.1
24-hour: 8.0

Dissolved oxygen:

0-hour: 95-96%
24-hour: 95-100%

Nominal and measured concentrations:

Nominal: 1.0, 1.8, 3.2, 5.8, 10, 18, 32, 58, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers covered with watch glasses
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 mL solution/beaker
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light, 16 hours daily
- Light intensity: approx. 1500 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

34 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobility

Remarks on result:

other: 95% confidence limit

Remarks:

22.5-57.3 mg/L

Details on results:

Immobilizaztion was 0, 0, 0, 5, 10, 35, 60, 55, 55, and 60% at 0, 1.0, 1.8, 3.2, 5.8, 10, 18, 32, 58, and 100 mg/L.

Reported statistics and error estimates:

The EC50 values were calculated according to the maximum likelihood method, probit model (Mc Cullagh, P., Nelder, J.A., 1983: Generalised linear models. Chapman & Hall, London). EC-values were graphically determined on gausso-logarithmic probability paper.

Conclusions:

24-hour EC50 (Daphnia magna): 34 mg/L

Executive summary:

The ability of the test substance to cause effects to Daphnia magna was examined in a test in accordance with procedures detailed in Official Journal of the European Communities

L 251,vol.27,C-02,19/09/1984. Twenty Daphnia (4 replicates of 5 Daphnia each) per concentration and control were exposed to nominal concentrations of 1.0, 1.8, 3.2, 5.8, 10, 18, 32, 58, and 100 mg/L. The 24-hour EC50 was 34 mg/L.

Description of key information

No acute daphnia study with the test substance is available. A study in accordance with OECD Guideline 203 with N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide] was used as read across to fulfil the data gap for the test substance. The underlying hypothesis supporting read-across from the source (N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]; CAS 23128-74-7) to the target (N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]; CAS 69851-61-2) includes the following: (1) Structural similarity, (2) Source and target are expected to hydrolyse in a similar fashion, (3) Source and target have similar predicted metabolism, (4) Source and target have similar physicochemical properties, (5) Source and target have similar calculated chemical descriptors, and (6) Source and target have similar predictions for the endpoints of concern. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.

The ability of the test substance to cause effects to Daphnia magna was examined in a test in accordance with OECD guideline 202. Twenty Daphnia (4 replicates of 5 Daphnia each) per concentration and control were exposed to nominal concentrations of 10, 18, 32, 58, and 100 mg/L. The 24-hour EC50 was 82 mg/L.

The ability of the test substance to cause effects to Daphnia magna was examined in a test in accordance with procedures detailed in Official Journal of the European Communities L 251,vol.27,C-02,19/09/1984. Twenty Daphnia (4 replicates of 5 Daphnia each) per concentration and control were exposed to nominal concentrations of 1.0, 1.8, 3.2, 5.8, 10, 18, 32, 58, and 100 mg/L. The 24-hour EC50 was 34 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

34 mg/L