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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Aliquots of the samples from the biological test were directly analysed by HPLC and UV/VIS-detection (range of the injection volume: 100 μL, depending on the expected concentration).
The test item consists of three components. Only two components can be detected. The results are reported as sum of the two components.
Vehicle:
no
Details on test solutions:
Reconstituted water (so-called 'M4 medium' according to OECD 202) was used for the maintenance of the test animals and the preparation of stock and test solutions of the test item.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
14.4°dH (= 257 mg/L CaCO3)
Test temperature:
21.6°C
pH:
7.9
Dissolved oxygen:
8.6 mg/L (=95 % saturation)
Nominal and measured concentrations:
nominally 100 mg/L
Details on test conditions:
Pre-treatment of test item and preparation of test item concentrations:
To produce the only effective loading a Water Accommodated Fraction (WAF) was prepared daily for the test con-centration 100 mg/L. To achieve this 105.3 mg on 2012-03-26 and 105.4 mg on 2012-03-27 of the test item were added each to 1 litre of dilution water, treated for 60 seconds at 8000 rpm with an ultra turrax and then stirred for 24 h on a magnetic stirrer. Undissolved particles of the test item were removed by filtration using a folded filter with a pore size of 7-12 μm and an aseptic filter Sartobran 150 Sterile Capsule with a pore size 0.45 + 0.2 μm. The pH was measured to be 7.9 on 2012-03-27 and 7.8 on 2012-02-28.
19 mL of the solution were taken and diluted with 1 mL of dilution water containing 10 daphnids resulting in the final loading. For each loading and the control 2 replicates were prepared.
Exposure conditions:
Test vessels : 50 mL glass beakers covered with watch glasses
Experimental design : 1 test concentration plus 1 control
10 neonates per vessel, 2 replicates per concentration/control, no feeding during the exposure period
semi static system
Method of initiation : neonates were placed in prepared media
Photoperiod : 16 h light : 8 h dark
Temperature of incubation unit : 19.8 to 20.5 °C
Aeration : none
Test item concentration/s : 100 mg/L
Method of administration : direct weighing
Medium renewal : daily
Duration of exposure: 48 hours
Criteria of effects : The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours.
Duration:
24 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
For 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' no toxic effects against daphnia were observed at a limit Effective Loading of 100 mg/L, corresponding to a measured concentration of < 0.131 mg/L, which reflects the maximum water solubility under exposure conditions.
All results are expressed in terms of Effective Loadings (EL). In the freshly prepared test medium and in the medium after 24 hours of exposure the values were below the quantification limit of the HPLC analysis (0.131 mg/L).
'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' consists of three components, therefore a Water Accommodated Fraction (WAF) was used to test effects at a limit effective loading of 100 mg/L.
Validity criteria fulfilled:
yes
Remarks:
The immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test. The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.
Conclusions:
The acute toxicity of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to Daphnia magna was investigated in a semi static test according to EU Method C.2 (Acute Toxicity for Daphnia). No toxic effects against daphnia were observed at a limit Effective Loading (EL50) of > 100 mg/L, corresponding to a measured concentration of < 0.131 mg/L, which reflects the maximum water solubility under exposure conditions.
Executive summary:

A study was performed to assess the acute toxicity of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to Daphnia magna STRAUS under semi static conditions.

The study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Im-mobilisation Test' (adopted April 13, 2004).

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer, folded filters and aseptic filters. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure.

No toxic effects against daphnia were observed at a limit Effective Loading of 100 mg/L, corresponding to a measured concentration of < 0.131 mg/L, which reflects the maximum water solubility under exposure conditions.

All results are expressed in terms of Effective Loadings (EL). In the freshly prepared test medium and in the medium after 24 hours of exposure the values were below the quantification limit of the HPLC analysis (0.131 mg/L).

'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' consists of three components, therefore a Water Accommodated Fraction (WAF) was used to test effects at a limit effective loading of 100 mg/L.

This toxicity study is classified asacceptable and satisfies the guideline requirements for the acute Daphnia study.

Description of key information

The acute toxicity of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to Daphnia magna was investigated in a semi static test. No toxic effects against daphnia were observed at a limit Effective Loading (EL50) of > 100 mg/L, corresponding to a measured concentration of < 0.131 mg/L, which reflects the maximum water solubility under exposure conditions.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

A study was performed to assess the acute toxicity of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' to Daphnia magna STRAUS under semi-static conditions.

The study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Im-mobilisation Test' (adopted April 13, 2004).

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of 'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer, folded filters and aseptic filters. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure.

No toxic effects against daphnia were observed at a limit Effective Loading of 100 mg/L, corresponding to a measured concentration of < 0.131 mg/L, which reflects the maximum water solubility under exposure conditions.

All results are expressed in terms of Effective Loadings (EL). In the freshly prepared test medium and in the medium after 24 hours of exposure the values were below the quantification limit of the HPLC analysis (0.131 mg/L).

'Reaction mass of benzyl 2-ethylhexyl adipate and bis(2-ethylhexyl) adipate and dibenzyl adipate' consists of three components, therefore a Water Accommodated Fraction (WAF) was used to test effects at a limit effective loading of 100 mg/L.