DL-serinohydrazide monohydrochloride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 - 25 Jan 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Remarks:

Federal Office of Public Health, Bern, Switzerland

Test material

Test material information

Constituent 1

Reference substance name:

DL-serinohydrazide monohydrochloride

EC Number:

259-839-8

EC Name:

DL-serinohydrazide monohydrochloride

Cas Number:

55819-71-1

Molecular formula:

C3H9N3O2.ClH

IUPAC Name:

2-amino-3-hydroxy-propanehydrazide;hydrochloride

Details on test material:

- Name of test material (as cited in study report): DL-Serine hydrazide HCl
- Substance type: white solid
- Physical state: solid
- Expiration date of the lot/batch: 06 Dec 2001
- Storage condition of test material: in refrigerator at about 4 °C, under N2

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

For the analysis of the actual test item concentrations the following samples were taken:
Just before test start: duplicate samples from the test medium (without daphnids); duplicate samples from the control (without daphnids)
After 48 hours (stability samples): duplicate samples from the test medium; duplicate samples from the control
For the 48-hour stability samples, the contents of the two respective test beakers were combined.
All the samples as listed below were analyzed immediately after sampling since a significant loss of test item was determined in deep-frozen test medium samples (results of a pre- experiment, without GLP).
The concentration of the test item DL-Serine hydrazide HCl was analyzed in the duplicate test medium samples of the single test concentration for both sampling times (0 and 48 hours).
From the control, only one of the duplicate samples was analyzed from each of both sampling times.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium of the only test concentration of nominal 100 mg/L was prepared by dissolving 30 mg test item completely in 300 mL test water by intense stirring for five minutes at room temperature. The test medium was prepared just before introduction of the daphnids (= start of the test). The actual concentration of the test item in the test medium was analytically determined.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: clone 5
- Source: The clone of this species was originally supplied by the University of Sheffield/UK in 1992. Since this date the clone is bred in the laboratories of RCC in reconstituted water of the quality identical to the water quality used in the tests (regarding pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests.
- Age at study initiation (mean and range, SD): 6 - 24 hours old, not first brood progeny

ACCLIMATION
- Acclimation conditions (same as test or not): yes

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20 °C

pH:

6.9 - 7.9

Dissolved oxygen:

8.3 - 8.6 mg O2/L

Nominal and measured concentrations:

control, 100 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 100 mL glass beakers filled with 50 mL test medium
- Aeration: none during test period
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: < 1 Daphnia per 2 mL test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Reconstituted water: analytical grade salts were dissolved in purified water to obtain the following nominal concentrations:
CaCI2 x 2H2O: 2.0 mmol/L (= 294.0 mg/L)
MgS04 x 7H2O: 0.5 mmol/L (= 123.0 mg/L)
NaHCO3: 0.75 mmol/L (= 65.0 mg/L)
KCI: 0.075 mmol/L (= 5.8 mg/L)
Water Hardness: 2.5 mmol/L (= 250.0 mg/L) as CaCO3
Alkalinity: 0.8 mmol/L
Ratio of Ca:Mg = 4:1 (based on molarity), Na:K = 10:1 (based on molarity)

- Intervals of water quality measurement: At the start and at the end of the test, the pH values, the dissolved oxygen concentrations, and the water temperature were determined in the single test concentration and the control. The appearance of the test medium was recorded at the start of the test and after 24 and 48 hours.


OTHER TEST CONDITIONS
- Photoperiod: 16-hour light to 8-hour darkness with 30 min transition period
- Light intensity: 200 - 1200 Lux during light period

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): observed for immobility or mortality after 24 and 48 hours of exposure

TEST CONCENTRATIONS
- Range finding study: yes; The test concentration was based on the results of a range-finding test and on results of a pre-experiment to the solubility of the test item (without GLP).

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No mortalities or sublethal effects were observed.

Any other information on results incl. tables

Analytical results:

The analytically determined test item concentration in the test medium at the start and the end of the test was 91 and 90% of the nominal value, respectively. Under the test conditions, the test item DL-Serine hydrazide HCl was sufficiently stable during the test period of 48 hours. Therefore, all reported results are related to the nominal concentration of the test item.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study no adverse effects to Daphnia magna were observed. The EC50 and NOEC were determined to be >100 mg/L and 100 mg/L, respectively. Analytical measurement showed the test item to be sufficiently stable. All validity criteria were fulfilled.

Executive summary:

The acute toxicity of the test item DL-Serine hydrazide HCI to Daphnia magna was determined in a 48-hour static test according to the EU Commission Directive 92/69/EEC, Part C.2 (1992), and the OECD Guideline for Testing of Chemicals, No. 202, Part I (1984).

A limit test was performed in accordance with the EU Commission Directive 92/69/EEC to demonstrate that the test item has no toxic effect on the test organisms up to and including the concentration of nominal 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L and a control.

During the test period, the test item concentration in the duplicate samples from the start and the end of the test was 91 and 90% of the nominal value, respectively. Under the test conditions, the test item DL-Serine hydrazide HCI was sufficiently stable during the test period of 48 hours. Therefore, all reported results are related to the nominal concentration of the test item.

In the control and at the test item concentration of 100 mg/L, no immobilized or dead test organisms or other signs of intoxication were determined during the test period of 48 hours.

No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution throughout the whole test duration.

At the beginning and the end of the test period, the dissolved oxygen concentrations in the test medium and the control were at least 8.3 mg/l. The pH in the control was at the start and end of the test 7.9. The pH in the test medium was 6.9 at the test start and 7.6 at the end of the exposure period.

The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 of DL-Serine hydrazide HCI to Daphnia magna were determined to be at least 100mg/L. These values might even be higher, but concentrations in excess of 100 mg/L were not tested according to the EU Commission Directive. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of DL-Serine hydrazide HCI at the test concentration of 100 mg/L.