Diundecyl phthalate

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

GLP compliant study conducted in accordance with internationally recognised test methods.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity Test)

Version / remarks:

Methodology as described in EPA TSCA 40 CFR Part 797.1600, now superseded by OPPTS 850.1400

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Sampling method:
Routine confirmations of test concentrations routine were performed by 14C liquid scintillation spectroscopy (LS) of water samples from the test aquaria. Samples were collected from at least one of two replicate aquaria (alternated weekly) on days -2, -1, 0, 1 , 7, 14, and weekly thereafter throughout the study.
Quality control samples were conducted. Duplicate 10-ml samples of test solution were collected for analysis by LS.
Additional confirmatory analyses were performed using HPLC or GC. Periodically during the study, 125- to 500-ml samples were collected from each of two replicate test aquaria and analyzed.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: prepared by mixing the appropriate amount of test chemical into vehicle
- Controls: yes, vehicle control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): small droplets and an oily sheen were observed on the surface of the exposure chamber early in the test. The standpipe drain sleeves were removed from that chamber so that the surface would be skimmed off during diluter cycling.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs): No data
- Method of collection of fertilised eggs: at study initiation newly 40-60 fertilized eggs (<4.5 h postfertilization) were impartially distributed to glass incubation cups suspended in the test chamber.
- Subsequent handling of eggs: To facilitate test solution circulation and to keep the eggs clean, the incubation cups were oscillated vertically in each test chamber by means of a rocker arm apparatus driven by a low rpm electric motor. On day 25 of each test, embryos were impartially reduced to 20 eyed embryos in each cup.

POST-HATCH FEEDING
- Start date: at the start of swim-up.
- Type/source of feed: commercially prepared Salmon Starter@ (Zeigler Bros, Gardners, PA) in combination with live brine shrimp nauplii (Artemia sp.)
- Amount given: no data
- Frequency of feeding: two to three times each day

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

155 d

Remarks on exposure duration:

120 d post hatch

Post exposure observation period:

None

Hardness:

158 to 198 mg/L (as CaCO3)

Test temperature:

10 ± 1.5ºC during egg incubation and gradually increased to 12 ± 5ºC during the growth phase.

pH:

7.0-8.6

Nominal and measured concentrations:

mean measured concentrations: 0.000, 0.026, 0.039, 0.075, 0.15, 0.30 mg/L

Details on test conditions:

TEST SYSTEM
- Emybro cups (if used, type/material, size, fill volume): Incubation cups were constructed from glass or polyethylene tubing or jars with Nitex or stainless steel screen forming the bottom.
- Test vessel: aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass aquaria (27 x 74.5 x 30.5 cm) with 17.5-cm-high standpipe drains, 35 L.
- Aeration: On day 119 pure oxygen was added to the dilution water. On day 144, gentle aeration of the test aquaria solutions, in addition to oxygenation of the water entering the diluter, was initiated.
- Type of flow-through (e.g. peristaltic or proportional diluter): 50% proportional diluter system, similar to that described by Mount and Brungs (Mount, D.I. and W.A. Brungs. 1967).
- Renewal rate of test solution (frequency/flow rate): 5.4-9.6 volumes/day
- No. of fertilized eggs/embryos per vessel: initially 40-60 eggs reduced to 20 eyed embryos on day 25.
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 117 to 216 mg/L (as CaCO3)
- Culture medium different from test medium: No
- Intervals of water quality measurement: Measurements were made in one or more replicates at intervals ranging from once daily to once weekly.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: darkness or very low light conditions through hatch then 14:10 light: dark (with simulated dawn and dusk transition period)
- Light intensity: 45 to 55 lumens/ft2 (7.12 to 8.70 W/m2)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Egg hatchability/survival, fry survival, and growth (length and weight). At regular intervals during the tests, standard length of live fish was determined photographically. At the end of the tests, photographic length measurements were made and the fish were sacrificed and measured individually for standard length and blotted wet weight.

VEHICLE CONTROL PERFORMED: yes

POST-HATCH DETAILS
- Begin of post-hatch period: approximately 35 d postfertilization.
- No. of hatched eggs (alevins)/treatment released to the test chamber: Not reported
- Release of alevins from incubation cups to test chamber on day no.: after hatch on day 35

Reference substance (positive control):

no

Key result

Duration:

155 d

Dose descriptor:

NOEC

Effect conc.:

0.3 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: No effects were observed at all test concentrations

Key result

Duration:

155 d

Dose descriptor:

NOEC

Effect conc.:

0.3 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

number hatched

Remarks on result:

other: No effects were observed at all test concentrations

Key result

Duration:

155 d

Dose descriptor:

NOEC

Effect conc.:

0.3 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: No effects were observed at all test concentrations

Results with reference substance (positive control):

N/A

Validity criteria fulfilled:

yes

Conclusions:

In a long-term aquatic toxicity test to rainbow trout (Oncorhynchus mykiss) conducted in flow-through conditions, the NOEC of the test substance was determined to be 0.30 mg/L as no effects were observed at any concentration tested.

Executive summary:

Long-term toxicity to fish was determined for diundecyl phthalate (DUP) in an early-life stage toxicity test with rainbow trout ( Oncorhynchus mykiss) conducted following the procedures described in EPA TSCA 40 CFR Part 797.1600 and according to GLP standards. A preliminary range finding study was performed to determine the concentration range for the definitive exposures. The main test was performed in duplicate with concentrations of 0.000, 0.026, 0.039, 0.075, 0.15 and 0.30 mg/L (mean measured) for a period of 155 days (120 days post hatch) in flow-through conditions. The test substance was diluted in acetone which was also tested as vehicle control. Small droplets and an oily sheen were observed on the surface of the exposure chamber in the two highest concentrations. No effects were observed on hatchability, survival, or growth during the test at any concentration tested. Based on these results, the NOEC, based on the mean measured concentration, was 0.30 mg/L, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.

Description of key information

Key study: Method according to EPA TSCA 40 CFR Part 797.1600, GLP study. The NOEC of DUP was determined to be 0.30 mg/L, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.3 mg/L

Additional information

Key study: Long-term toxicity to fish was determined for diundecyl phthalate (DUP) in an early-life stage toxicity test with rainbow trout ( Oncorhynchus mykiss) conducted following the procedures described in EPA TSCA 40 CFR Part 797.1600 and according to GLP standards. A preliminary range finding study was performed to determine the concentration range for the definitive exposures. The main test was performed in duplicate with concentrations of 0.000, 0.026, 0.039, 0.075, 0.15 and 0.30 mg/L (mean measured) for a period of 155 days (120 days post hatch) in flow-through conditions. The test substance was diluted in acetone which was also tested as vehicle control. Small droplets and an oily sheen were observed on the surface of the exposure chamber in the two highest concentrations. No effects were observed on hatchability, survival, or growth during the test at any concentration tested. Based on these results, the NOEC, based on the mean measured concentration, was 0.30 mg/L, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.