Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions, not GLP
according to guideline
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
Part 1, adopted 25 April 1984
GLP compliance:
Analytical monitoring:
Details on test solutions:
- Method: test substance concentrations of 100 and 1000 mg/l were moderately stirred in test medium for 24 h at room temperature, after this the undissolved materials were removed by filtration (MILLIPORE glass fibre filter AP15), the resulting water accommodated fractions (WAFs) were used in the test
- Controls: test medium
Test organisms (species):
Daphnia magna
Details on test organisms:
- Common name: water flea
- Strain: Straus, 1820
- Method of breeding: Parental and young daphia were held in 250 l glass aquaria in continuously aerated reconstituted water, feeded once a day with boiled supernatant of 1:1 mixture of Sera micropan and Sera vipan (Sera aparistic GmbH, Germany) prepared with tap water
- Feeding during test: none

- Acclimation period: 4 hours
- Acclimation conditions (same as test or not): yes
- Health during acclimation (any mortality observed): no data
Test type:
Water media type:
Limit test:
Total exposure duration:
48 h
Remarks on exposure duration:
2 test substance concentrations (100 and 1000 mg/l nominal) were tested as WAF's
2.5 mmol/l
Test temperature:
20 +/- 0.5 °C
7.3 - 7.7
Dissolved oxygen:
6.7 - 7.7 mg/l
Nominal and measured concentrations:
100, 1000 mg/l nominal concentrations were tested as water accommodated fractions (WAFs), separately prepared
Details on test conditions:
- Test vessel: 100 ml flasks, all-glas with 50 ml of test medium
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 3

- Source/preparation of dilution water: reconstituted water (ISO 6341 (5)), prepared with distilled water (conductivity < 1.5 µS/cm), containing 25 m/L of each of the following stock solutions: CaCl2 x 2 H2O, 11.76 g/l; MgSO4 x 7 H2O, 4.93 mg/l; NaHCO3, 2.59 g/l; KCl, 0.23 g/l
- Alkalinity: 0.8 mmol/l
- Ca/Mg ratio: 4:1
- Na/K ratio: 10:1
- Culture medium different from test medium: no

- Adjustment of pH: not adjusted
- Photoperiod: 16 h
- Light intensity: overhead white fluorescent tubes, no further details mentioned

- Temperature: in a control flask at the start and the end of the test
- Oxygen, pH: in all vessels prior to the addition of daphnia and at the end of the test
- Mobility: observations of mobility of daphnia after 24 and 48 h of exposure
Reference substance (positive control):
potassium dichromate
Key result
48 h
Dose descriptor:
Effect conc.:
> 1 000 mg/L
Nominal / measured:
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
Details on results:
Immobilization data:
Control: 0/60 (0%) after 24h, 1/60 (1.7%) after 48h
100 mg/l (nominal concentration): 0/40 (0%) after 24h, 2/40 (10%) after 48h
1000 mg/l (nominal concentration):0/40 (0%) after 24h, 7/40 (17.5%) after 48h
Results with reference substance (positive control):
periodically conducted in the testing laboratory, no further details mentioned
Validity criteria fulfilled:
All values (pH, oxygen, temperature) were within an acceptable range, immobilized Daphnia in the control < 10%.
Based on the result of the study it can be concluded that the EL50 value after 48 h of exposure is > 1000 mg/l nominal concentration (tested as WAF).
Executive summary:

The acute toxicity of Diisotridecyl adipate to Daphnia magna was investigated under static exposure condition over a period of 48 h. The only applied nominal test concentrations were 100 amd 1000 mg/l.

40 individual Daphnia devided in 2 test vessels were exposed to each concentration of the test substance.

Due to the limited water solubility of the test substance, Diisotridecyl adipate in a concentration of 100 and 1000 mg/l, respectively, was moderately stirred in Daphnia medium for 24 h at room temperature. After this incubation time, the undissolved materials were removed by filtration. The resulting water accomodated fractions were used for the test. No chemical analysis of the test media was conducted.

At the nominal concentrations of 100 and 1000 mg/l no immobilization of Daphnia were observed after 24 h of exposure. At the loading rate of 1000 mg/l 17.5 % of Daphnia were immobile after 48 h of exposure. At 100 mg/l 10 % immobile Daphnia were observed after 48 h of exposure. No toxic effects (<= 5% immobilization) were observed in the control after 24 and 48 h of exposure, respectively.

Based on the results of the study it can be concluded that the 24 and 48 h EL50 values of Diisotridecyl adipate is >1000 mg/l nominal concentrations.

Description of key information

EL50(48h) > 1000 mg/L (nominal, loading rate) for immobilisation of Daphna magna (OECD 202)

Key value for chemical safety assessment

Additional information

To assess the short-term toxicity of diisotridecyl adipate to aquatic invertebrates, three tests with Daphnia magna are available. The acute toxicity of diisotridecyl adipate to Daphnia magna was investigated under static exposure conditions over a period of 48 h. The only applied loading rates were 100 and 1000 mg/l. Based on the results of the study it can be concluded that the 24 h and 48 h EL50 values of the test substance diisotridecyl adipate is >1000 mg/l (Häner/Panolin, 1998).

The supporting substance bis (2–ethylhexyl) adipate was tested over a period of 48 hours (BASF, 1988). The acute toxicity of bis (2-ethylhexyl) adipate to water fleas was studied under static conditions in a Daphnia magna immobilization test similar to OECD test guideline 202. Daphnids were exposed to nominal concentrations of 0 (control), 15.62, 31.2, 62.5, 125, 250, and 500 mg/L test substance. To increase solubility a vehicle was used (Tween 80). In controls and vehicle controls, no immobilization of daphnids was observed. The 48-h EC50 based on immobilisation was determined to be > 500 mg/L (BASF, 1988).

In the third avalaible acute Daphnia magna study, diisotridecyl adipate was tested over a period of 24 h in a non-GLP study (Rabe/Mobil 1997).