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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976-04 to 1977-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
not specified
GLP compliance:
no
Remarks:
the study pre-dates GLPs
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
N/A
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations
- Sampling method: Samples were taken from test vessels on day 0, and every 3-5 days throughout the 21-day test.
- Sample storage conditions before analysis: Preserved with 1% formaldehyde for anionics, or H2SO4 at pH 2 for nonionics, and stored at 5 C until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct dilution of the appropriate amount of test substance into blended well water
- Eluate: N/A
- Differential loading: N/A
- Controls: Blended well water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): N/A
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): N/A
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: N/A
- Justification for species other than prescribed by test guideline: N/A
- Source: In-house culture
- Age of parental stock (mean and range, SD): <12 h
- Feeding during test
- Food type: ground trout chow/alfalfa mixture, 1000 mg/L
- Amount: 5 mg/L
- Frequency: Each diluter cycle


ACCLIMATION
- Acclimation period: Not specified
- Acclimation conditions (same as test or not): N/A
- Type and amount of food: N/A
- Feeding frequency: N/A
- Health during acclimation (any mortality observed): N/A


QUARANTINE (wild caught)
- Duration: N/A
- Health/mortality: N/A


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Young were manually siphoned from existing culture units
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
None
Hardness:
120 +/- 18 mg/L CaCO3
Test temperature:
21 +/- 1 C
pH:
7.5 +/- 0.2 SU
Dissolved oxygen:
8.9 +/- 0.4 mg/L
Salinity:
N/A
Nominal and measured concentrations:
Mean Measured Concentrations - Control, 0.08, 0.17, 0.34, 0.70, and 1.35 mg/L C12.7 Amine Oxide (active ingredient). Nominal concentrations not available in the study report.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 1 liter glass beakers, 1 L test solution
- Aeration: N/A
- Type of flow-through (e.g. peristaltic or proportional diluter): Mount and Brungs proportional diluter, with modifications
- Renewal rate of test solution (frequency/flow rate): 125 ml per 20 min cycle, or one chamber volume every 2.5 hr.
- 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): N/A
- Biomass loading rate: N/A


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Blended well water
- Total organic carbon: N/A
- Particulate matter: N/A
- Metals: N/A
- Pesticides: N/A
- Chlorine: N/A
- Alkalinity: N/A
- Ca/mg ratio: N/A
- Conductivity: N/A
- Salinity: N/A
- Culture medium different from test medium: No
- Intervals of water quality measurement: Daily


OTHER TEST CONDITIONS
- Adjustment of pH: N/A
- Photoperiod: N/A
- Light intensity: N/A


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, 24 hr, 96 hr, 7 days, then daily to end of test. Reproduction, daily beginning day 7 or 8 to end of test.


VEHICLE CONTROL PERFORMED: no


RANGE-FINDING STUDY
- Test concentrations: N/A
- Results used to determine the conditions for the definitive study: N/A
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.01 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL 0.85-1.21 mg/L
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
0.96 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL 0.90-1.03 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.88 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: Total young production
Remarks on result:
other: 95% CL 0.77-1.04 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
1.01 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: Average brood size
Remarks on result:
other: 95% CL 0.95-1.07 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
1.04 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: Percentage of days reproduction occurred
Remarks on result:
other: 95% CL 0.98-1.11 mg/L
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
other: Parent (Fo) Survival and Reproduction (Mean Brood Size; Total # of young)
Remarks on result:
other: CL not provided
Details on results:
- Mortality of parent animals: % mortality, day 21- Control-10%; 0.08 mg/L-30%; 0.17 mg/L-20%; 0.34 mg/L-10%, 0.70 mg/L-15%; 1.35 mg/L-100%
- No. of offspring produced per day per female: N/A
- Body length and weight of parent animals: N/A
- Type and number of morphological abnormalities: N/A
- Type and number of behavioural abnormalities: N/A
- Number of males and females (parental): N/A
- Time to first brood release or time to hatch- 7 or 8 days
- Egg development time: N/A
- Brood size: Mean-Control-1.78; 0.08 mg/L-2.92; 0.17 mg/L-5.32; 0.34 mg/L-5.58, 0.70 mg/L-6.06; 1.35 mg/L-0
- Time to sexual maturity: N/A
- Type and magnitude of biochemical changes: N/A
- Other biological observations: N/A
- Effect concentrations exceeding solubility of substance in test medium: N/A
Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
All results were calculated with a computerized probit analysis program after Finney (1964, 1971). Survival data for 96 hr and 21 days was used to calculate LC50 values and confidence limits. All results were calculated based on mean measured concentrations of test material.
Validity criteria fulfilled:
yes
Conclusions:
The 21 day NOEC of C12/C14 amine oxide to Daphnia magna was 0.70 mg AO/L, based on survival and reproduction. The 21 day LC50 was 0.96 mg AO/L. Results are based on the mean measured concentration.
Executive summary:

The long-term toxicity of C12/C14 amine oxide was evaluated in a 21 day survival and reproduction test with Daphnia magna, following the OECD 211 guideline. Four replicates per concentration, 5 organisms per replicate, were tested in a flow-through system (a modified Mount and Brungs proportional diluter). Mean measured test concentrations were: Control, 0.08, 0.17, 0.34, 0.70, and 1.35 mg AO/L.

Survival was monitored at 24 hr., 96 hr., 7 days, and daily thereafter. Reproduction was monitored beginning with the production of the first brood on day 7 or 8, and daily thereafter. LC50s and EC50s were calculated by probit analysis. Results are based on the mean measured concentration of the active ingredient. The 21 -day NOEC was 0.70 mg AO/L, based on both survival and reproduction. The 21 day LC50 was 0.96 mg AO/L (95% CL = 0.90 -1.03 mg AO/L). The 21-day EC50’s, based on total young production, average brood size, and % days reproduction occurred, were 0.88 mg AO/L, 1.01 mg AO/L, and 1.04 mg AO/L, respectively.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Read across based on an OECD 211 study performed with C12/14 Amine Oxide. The read across justification document is attached in IUCLID Section 13.
Reason / purpose:
read-across source
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other:
Remarks:
The 21 day NOEC of C12/C14 amine oxide to Daphnia magna was 0.70 mg AO/L, based on survival and reproduction. The 21 day LC50 was 0.96 mg AO/L.

Description of key information

No chronic daphnia toxicity studies have been performed using C12-C18 AAAO. Data are read across from C12-C14 Amine Oxide (C12-C14 AO), a structurally similar substance for the C12-C18 AAAO substance. One long-term (21 days) toxicity to Daphnia magna study is available for C12-C14 AO. A No effect concentration of 0.7 mg AO/L was reported in the study.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.7 mg/L

Additional information

No chronic daphnia toxicity studies have been performed using C12 -C18 AAAO compound. However, data are available for C12-14 AO, a similar substance to which C12-C18 AAAO can be read across.

The long-term toxicity of the C12-14 AO was evaluated in a 21 day survival and reproduction test with Daphnia magna, following the OECD 211 guideline [Maki AW (1977)]. Four replicates per concentration, 5 organisms per replicate, were tested in a flow-through system. Mean measured test concentrations were: 0, 0.08, 0.17, 0.34, 0.70, and 1.35 mg AO/L.

Survival was monitored at 24 hours, 96 hours, 7 days, and daily thereafter. Reproduction was monitored beginning with the production of the first brood on day 7 or 8, and daily thereafter. LC50s and EC50s were calculated by probit analysis. Results are based on the mean measured concentration of the amine oxide. The 21 -day NOEC was 0.70 mg AO/L, based on both survival and reproduction. The 21 day LC50 was 0.96 mg AO/L. The 21-day EC50’s, based on total young production, average brood size, and % days reproduction occurred, were 0.88 mg AO/L, 1.01 mg AO/L, and 1.04 mg AO/L, respectively.

The justification for read-across within this endpoint can be found in Annex 1 of the Chemical Safety Report: "Justification of the analogue approach".