Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-299-9 | CAS number: 27178-16-1
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- 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
- 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
- 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
Referenceopen allclose all
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.
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.
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:
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
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
