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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Principles of method if other than guideline:
The study was performed according to European standard test guideline, Directive 79/831/EWG, appendix V, part C, stand Nov 1989.
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
- concentration of the stock solution: 100 mg/l.
- stock solution mixed for 1020 minutes at 20 degree with Cremophor RH 40 (100 mg/l).
- stock solution diluted with test water
- 10 ml of the diluted test substance added to each test vessel
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISMS
- Test organism: Daphnia magna STRAUS
- Supplier: Institut National de Recherche Chimique Appliquee, France

CULTIVATION
- temperature: 20°C
- photoperiod: 16 h light / 8 h dark
- daily feeding with green algae
- cultivation water was identical to test water
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
Total hardness: approx. 2.7 mmol/l
pH:
approx. 8.0
Dissolved oxygen:
> 2 mg/l
Nominal and measured concentrations:
- test concentrations nominal (mg/l): 0.049, 0.098, 0.195, 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50, 100
Details on test conditions:
TEST CONDITIONS
- 20 ml test tubes
- 10 ml test volume
- 5 test organims per test tube
- 20 test organisms per concentration (4 replicates)
- age of the test organisms: 2-26 hours
- not lighted
- test duration 48 hours
- determination of immobilisation after 3, 6, 24, and 48 hours
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
RS-Freetext:
RESULT IMMOBILISATION
EC 50 (3h): > 100 mg/l
EC 50 (6h): > 100 mg/l
EC 50 (24h): > 100 mg/l
EC 50 (48h): > 100 mg/l

immobilised organisms after 48 hours (from 20 organisms / conc.):
nom. conc. (mg/l ) 0h 3h 6h 24h 48h
(control) - - - - -
(cont. solubilizer) - - - - -
100 - - - 3 3
50 - - - 1 1
25 - - - - 2
12.5 - - - - 2
6.25 - - - - 2
3.13 - - - - 2
1.56 - - - - 1
0.78 - - - - -
0.39 - - - - -
0.195 - - - - -
0.098 - - - - -
0.049 - - - - -

RESULTS SYMPTOMS
At concentrations between 1.56 and 100 mg/l the test organisms swam partly at the surface.

REMARK
Effect concentration is greater than the solubility of the substance in the test medium.

OXYGEN CONTROL (mg/l)
nom. conc. (mg/l ) 0h 48h
(control) 9.1 8.9
(cont. solubilizer) 9.0 7.6
100 8.5 8.2
50 8.8 8.2
25 9.0 8.2
12.5 9.0 8.2
6.25 9.1 8.9
3.13 9.2 8.9
1.56 9.2 8.9
0.78 9.2 8.9
0.39 9.2 8.9
0.195 9.3 9.0
0.098 9.3 9.0
0.049 9.3 9.0

pH CONTROL 0h 48h
(control) 8.0 7.9
(cont. solubilizer) 8.0 7.8
100 7.7 7.7
50 7.9 7.8
25 8.0 7.8
12.5 8.0 7.9
6.25 8.0 7.9
3.13 8.1 7.9
1.56 8.0 8.0
0.78 8.1 7.9
0.39 8.1 8.0
0.195 8.1 8.0
0.098 8.1 8.0
0.049 8.0 7.9

Behavior of the test item during the test: No remarkable observations.
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 - 27 Apr 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution was prepared by mixing of 500 mg DEHA/L and 100 mg Tween 80/L. The stock solution was stirred for 10 min at 20 °C. The stock solution was diluted with tap water and 100 mg/L Tween 80 to prepare the different test concentrations. 10 mL of the respective test solution was added to the test vessel.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution): 100 mg/L
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISMS
- Source: inhouse culture originally obtained by Institut National de Recherche Chimique Appliquee, France
- Method of breeding: photoperiod: 16 h light / 8 h dark , daily feeding with green algae, once (after the change of water) feeding with yeast
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
2.44 mmol/L
Test temperature:
18 - 20 °C
pH:
7.41 - 7.84
Dissolved oxygen:
6.47 - 9.10 mg/L
Nominal and measured concentrations:
Nominal: 15.62, 31.2, 62.5, 125, 250, 500 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Centrifuge tube with 10 mL test solution
- 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

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: filtered (ac) and dechlorinated tap water
- Ca/mg ratio: 4:1
- Conductivity: 570 µS/cm
- Intervals of water quality measurement: at the beginning and the end of the test

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light: dark
- Light intensity: ~ 5 µE/m*m*s

EFFECT PARAMETERS MEASURED : Immobility was recorded after 3, 6, 24 and 48h exposure time.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
RS-Freetext:
RESULT IMMOBILISATION
EC 50 (3h): > 500 mg/l
EC 50 (6h): > 500 mg/l
EC 50 (24h): > 500 mg/l
EC 50 (48h): > 500 mg/l

immobilised organisms after 48 hours (from 20 organisms / conc.):
nom. conc. (mg/l ) 0h 3h 6h 24h 48h
(control) - - - - -
(cont. solubilizer) - - - - -
15.62 - - - - 1
31.2 - - - - 1
62.5 - - - - 1
125 - - - - 2
250 - - - - 2
500 - - - - 5

RESULTS SYMPTOMS
At concentrations between 100 and 500 mg/l the test organisms swam partly at the surface.

REMARK
Effect concentration is greater than the solubility of the substance in the test medium.

Behavior of the test item during the test: No remarkable observations.
Validity criteria fulfilled:
yes
Conclusions:
A 48h acute toxicity test according to EU method C.2 using Daphnia magna as test organism revealed that DEHA is not acutely harmful to freshwater invertebrates up to the saturation limit in water.
Executive summary:

The study was performed according to EU method C.2 using Daphnia magna as test organism. A stock solution of 500 mg/L was prepared by mixing with 100 mg Tween 80/L. The stock solution was diluted with tap water and 100 mg/L Tween 80 to prepare the different test concentrations. Nominal test concentrations between 15.62 and 500 mg/L were tested. Immobile daphnids were observed after 48h exposure time. A 48h-EC50 is determined to be > 500 mg/L. At concentrations between 100 and 500 mg/L the test organisms swam partly at the surface of the test vessels. Since the effect concentrations are greater than the solubility of DEHA in the test medium, it can be concluded that DEHA is not harmful to freshwater invertebrates up to the saturation limit in water.


Endpoint:
short-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:
48 h
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
250 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Endpoint:
short-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:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Description of key information

No relevant studies are available for diisodecyl adipate.

Two acute Daphnia toxicity studies are available for closely related, read-across substances:

A study was performed with bis(2-ethylhexyl) adipate (CAS 103-23-1, DEHA) according to EU method C.2 in Daphnia magna. A stock solution of 500 mg/L was prepared by mixing with 100 mg Tween 80/L. The stock solution was diluted with tap water and 100 mg/L Tween 80 to prepare the different test concentrations. Nominal test concentrations between 15.62 and 500 mg/L were tested. Immobile daphnids were observed after the 48h exposure time. A 48h EC50 was determined to be > 500 mg/L. At concentrations between 100 and 500 mg/L the test organisms swam partly at the surface of the test vessels.

Since the effect concentrations are greater than the solubility of DEHA in the test medium, it can be concluded that DEHA is not harmful to freshwater invertebrates up to the saturation limit in water.

The test with diisononyl adipate (CAS 33703-08-1) was conducted under static conditions similar to those described in OECD guideline 202 in Daphnia magna. Cremophor RH was used as vehicle at a concentration of 100 mg/L. Test concentrations of 0.049, 0.098, 0.195, 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50 and 100 mg/L were directly added to the test vessels.The EC50 (48h) was calculated as > 100 mg/L based on nominal concentration. 

Key value for chemical safety assessment

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