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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:
16 May - 13 Jun 2006
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
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Remarks:
HPLC-UV/VIS
Details on sampling:
- Concentrations: 0 and 100 mg/L
- Sampling method: Aliquots of the samples from the biological test were directly analysed by HPLC
- Sample storage conditions before analysis: Routinely, the samples are analysed immediately. Only in exceptional cases, they are stored overnight deeply frozen and protected from light.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: To produce the only test concentration 105.3 mg of the test item was added to 1 L of dilution water, then treated with an ultrasonic bath for 1 h and afterwards stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using a folded filter of pore size 7-12 µm.
- Controls: Yes
- Test concentration separation factor: Single concentration was used
- Evidence of undissolved material: undissolved particles of the test item were removed by filtration
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Strain of Bundesgesundheitsamt Berlin
- Stage and instar at study initiation: Neonates
- Method of breeding: Parthenogenesis (females)
- Source: Bundesgesundheitsamt Berlin
- Age of parental stock: maintained since more than 15 years in the test facility
- Feeding during test: no feeding during the exposure period
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
15.7 °dH (= 280.25 mg/L CaCO3)
Test temperature:
21.1 - 21.3 °C
pH:
7.8 - 8.2
Dissolved oxygen:
96 - 97 %
Nominal and measured concentrations:
Nominal = 100 mg/L
Measured = 96.098 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 50 mL glass beakers
- Volume of solution: 20 mL
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration: 2
- No. of vessels per control: 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (so-called 'M4 medium', originally described in Water Research 24 (9), September 1990: 1157-1167), prepared according to the recommendations of Bundesgesundheitsamt Berlin.
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light :8hdark

EFFECT PARAMETERS MEASURED:
Induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 h
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
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
Details on results:

- Other biological observations: none
- Mortality of control: 0 %
- Immobilisation of control: 0 %

 


Validity criteria for the measurement of the daphnia toxicity



































Target condition according to
guideline:
Actual condition according to
the study:
Validity criteria met:
pH should not vary by more than 1 unitpH range was 7.8 to 8.2Yes
In the control, including the solubilising agent, not more than 10 % of the daphnids should have been immobilized. (Not more than 10 % of the control daphnids should show immobilisation or other signs of disease or stress, for example, discoloration or unusual behaviour such as trapping at surface of water)No immobilization observed in controlYes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/l in control and test vessels.Dissolved oxygen concentration was atleast 8.5 mg/L in control and test vessels.Yes
A limit test may be performed at 100 mg/L of the test substance in order to demonstrate that the EC50 is greater than this concentration. The limit test should be performed using 20 daphnids, with the same number in the control. If the percentage of immobilisation exceeds 10% at the end of the test, a full study chould be conducted. Within the limit test, 20 daphnids were used for the test concentration of 100 mg/L (2 replicates and 10 daphnia per test vessel) and 20 daphnids for the control (2 replicates and 10 daphnia per test vessel). No immobilization of daphnids was observed within the test. Yes
The concentration of the test substance shall be maintained to within 80 % of the initial concentration throughout the course of the test.Recovery rates correspond to 96.0 % of nominal values at 0 h, and to 96.1 % of nominal values at 48 h, respectivelyYes

 

Validity criteria fulfilled:
yes
Remarks:
See more details in the table in the section "Any other information on results incl. tables"
Conclusions:
No toxic effects against daphnia at a concentration of 100 mg/L; 48h EC50 > 100 mg/L (nominal concentration) were observed.
Executive summary:

The 48 h-acute toxicity of the test substance to Daphnia magna was studied under static conditions in a limit test. The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (OJ. No. L383A, 29.12.92) Part C, Method 2 'Acute toxicity for Daphnia'. Test species were exposed to control and test chemical at nominal concentrations of 0 and 100 mg/L for 48 hr. Immobilisation and locomotion effects were monitored daily and no toxic effects were observed at the limit concentration of 100 mg/L. Therefore the 48 h EC50 was >100 mg/L. The results are expressed in terms of nominal concentrations. The test substance is an acid chloride which easily hydrolyses to the corresponding acid in aqueous media. Therefore the acid was analysed by HPLC. Recovery rates correspond to 96 % of nominal values at 0 hours and to 96.1% of nominal values at 48 hours, respectively.

Description of key information

A 48 h-acute toxicity of the test substance to Daphnia magna was studied under static conditions in a limit test. The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (OJ. No. L383A, 29.12.92) Part C, Method 2 'Acute toxicity for Daphnia'. Test species were exposed to control and test chemical at nominal concentrations of 0 and 100 mg/L for 48 hr. Immobilisation and locomotion effects were monitored daily and no toxic effects were observed at the limit concentration of 100 mg/L. Therefore the 48 h EC50 was >100 mg/L. The results are expressed in terms of nominal concentrations. The test substance is an acid chloride which easily hydrolyses to the corresponding acid in aqueous media. Therefore the acid was analysed by HPLC. Recovery rates correspond to 96 % of nominal values at 0 hours and to 96.1% of nominal values at 48 hours, respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
> 100 mg/L

Additional information