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Ecotoxicological information

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:
22 May - 12 Jun 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with analytical monitoring
Qualifier:
according to guideline
Guideline:
other: OECD 202, part 2 adopted in 1984
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 2 mg/L treatment
- Sampling method: A separate test concentration was prepared and used for testing the stability of the test substance in water.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution was prepared by by mixing 1 g test substance with 1 g vehicle in 1 L of dionized water. The stock solution was diluted to the respective test concentrations.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): MARLOWET R 40
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 2 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): not stated
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: own breeding
- Age of parental stock (mean and range, SD): < 24 hours
- Feeding during test
- Food type: green algae
- Amount: 0.5E7 cells/daphnid from day 0 to day 6; 1.0E7 cells/daphnid from day 7 to day 21
- Frequency: daily

HOUSING
- Housing medium: M4-medium (Elendt, 1990)
- Housing conditions: each test organism were kept separate in 60 mL test water
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
20 ± 1 °C
pH:
7.8 - 8.6
Dissolved oxygen:
94 - 107 mg/L
Nominal and measured concentrations:
Nominal test concentrations: 0.5, 1.0, 2.0 mg/L
Measured concentrations: 0.19, 0.39, 0.77 mg/L (geometric mean, biological active)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, total volume, fill volume: glass beakers, 150 mL, 100 mL
- Renewal rate of test solution (frequency): after 2, 6, 7, 9, 12, 14, 16, 19 days
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater according to Elendt (M4-medium)
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH-value and oxygen content of the new test solutions at day 2, 12, 16 and of the old test solutions at day 6, 14, 19.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: approx. 450 and 95 Lux

EFFECT PARAMETERS MEASURED: Immobility and reproduction was recorded after 2, 6, 7 9, 12, 14, 16, 19, 21 days.

VEHICLE CONTROL PERFORMED: yes
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: reproduction and survival
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: reproduction and survival
Details on results:
No significant effects were observed in up to the highest concentration tested.

Table 1: Results of test substance analytics

Nominal concentration [mg/L]

Determination

Fresh test solution

Old test solution (2 days)

geometric mean [mg/L]

2.0

1

1.8

< 0.05

-

2

1.8

0.86

-

3

1.9

0.12

-

mean

1.8

0.33

0.77

Validity criteria fulfilled:
yes
Conclusions:
A 21d long-term toxicity test with Daphnia magna revealed that DEHA does not cause adverse effects to reproduction and survival up to the saturation limit in water.
Executive summary:

The GLP study was performed according to OECD guideline 202, part 2 using Daphnia magna as test organism. Test concentrations from 0.5 to 2 mg/L were tested using Marlowet R40 as vehicle (2 mg/L). The stability of the highest test concentration (2 mg/L) was analytically examined. A geometric mean value of 0.77 mg/L was measured. No significant effects on reproduction and survival were observed up to the highest concentration tested. Thus, the 21d-NOEC value is determined to be > 0.77 mg/L (measured concentration) and > the solubility in water, 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
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Please see Section 13 below.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: reproduction and survival
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 0.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: reproduction and survival

Description of key information

No relevant studies are available for diisodecyl adipate.

A long-term toxicity study in Daphnia Magna is available for the closely related, read-across substance, bis(2-ethylhexyl) adipate (CAS 103-23-1). The GLP study was performed according to OECD guideline 202, part 2 using Daphnia magna as test organism. Test concentrations from 0.5 to 2 mg/L were tested using Marlowet R40 as vehicle (2 mg/L). The stability of the highest test concentration (2 mg/L) was analytically examined. A geometric mean value of 0.77 mg/L was measured. No significant effects on reproduction and survival were observed up to the highest concentration tested. Thus, the 21d-NOEC value is determined to be > 0.77 mg/L (measured concentration) and > the solubility in water, respectively.

Key value for chemical safety assessment

Additional information