trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

Short-term toxicity to aquatic invertebrates

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:

Feb 1993

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)

Version / remarks:

92/69

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: To produce the test concentration, 55.55 mg of the test substance were dissolved in 500 ml tap water.
- Controls: yes, 4 replicates

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): 0-24 h
- Stage and instar at study initiation: Neonates
- Source: Schering AG, Experimental Toxicology

ACCLIMATION
- Acclimation period: Parent animals were kept in glass vessels in water of the same quality and temperature as under experimental conditions.
- Acclimation conditions (same as test or not): same as test conditions

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

19.9 - 20.6 °C

pH:

7.7 - 8.5

Dissolved oxygen:

7.8 - 8.9 mg/L

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentration: 93-94% of nominal concentration

Details on test conditions:

TEST SYSTEM
- Test vessel: each test vessel was filled with 50 mL test solution
- Material, size, headspace, fill volume: fill volume of the test vessels was 100 mL
- No. of organisms per vessel: 5 animals
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Normal tap water was used as dilution water, not polluted with harmful concentrations of chlorine, heavy metals or other substances, based on quarterly measurements.
- Culture medium different from test medium: no
- Intervals of water quality measurement: quarterly measurements and in accordance with the "Trinkwasserverordnung"

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: light/dark rhythm 12/12 h

EFFECT PARAMETERS MEASURED
- immobilization was recorded after 24 and 48 h

Reference substance (positive control):

no

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:

- Mortality of control: no
- Immobilisation of control: no

Validity criteria for the measurement of the daphnia toxicity

Target condition according to guideline:	Actual condition according to the study:	Validity criteria met:
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)	Immobilization of control: 0%	Yes
The dissolved oxygen concentration at the end of the test should be >/= 3 mg/L in control and test vessels.	Dissolved oxygen concentration was 8.6 mg/L in control and test vessels.	Yes
The concentration of the test item shall be maintained to within 80% of the initial concentration throughout the study. The maintenance of concentration is proved by analytical measurements	Recovery rates correspond to 93% of nominal value at 0 hours and to 94% of nominal value at 48 hours.	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 (4 replicates and 5 daphnia per test vessel) and 20 daphnids for the control (4 replicates and 5 daphnia per test vessel). No immobilization of daphnids was observed within the test.	Yes

 

Validity criteria fulfilled:

yes

Remarks:

See 'Any other information on results incl. tables'.

Conclusions:

No toxic effect of the test substance against Daphnia up to 100 mg/L (nominal concentration) was observed; EC50(48h)>100 mg/L (nominal, equivalent to 93.5 mg/L measured) .

Executive summary:

The study was performed to assess the acute toxicity of the test substance to Daphnia magna under static conditions. The study was conducted in accordance with 92/69/EEC Part C, Method 2 'Acute toxicity for Daphnia' and the OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test and Reproduction Test, Part I- The 24h EC50 Acute Immobilisation Test'. The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of the test substance dissolved in water. Observations were made on the immobilisation of Daphnids after 24 and 48 hours of exposure. The following values were determined: EC50(48h)>100 mg/L nominal concentration (equivalent to 93.5 mg/L). Recovery rates correspond to 93% of nominal value at 0 hours and to 94% of nominal value at 48 hours. 

Description of key information

The study was performed to assess the acute toxicity of the test substance to Daphnia magna under static conditions. The study was conducted in accordance with 92/69/EEC Part C, Method 2 'Acute toxicity for Daphnia' and the OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test and Reproduction Test, Part I- The 24h EC50 Acute Immobilisation Test'. The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of the test substance dissolved in water. Observations were made on the immobilisation of Daphnids after 24 and 48 hours of exposure. The following values were determined: EC50 (48 h)>100 mg/L nominal concentration (equivalent to 93.5 mg/L). Recovery rates correspond to 93% of nominal value at 0 hours and to 94% of nominal value at 48 hours. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L