(2R,3S)-butane-2,3-diol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 June 1999 -17 June 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

guideline version from 1984

Justification for type of information:

Batch no. 34-2127
Date of production: December 1998
Colour: colourless/yellowish

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Sample preparation: To the whole sample (5 ml in a 10 ml vial) 4.5 ml drinking water and 0.5 ml IS solution were added.
The concentration control analyses were performed with test solutions of the following nominal concentrations (mg/l) of the test substance: 0 (control), 100, 12.5
At the start of the test (after 0 h) samples from vessels without daphnids, at the end of the test (after 48 h) samples from vessels with and without daphnids were analyzed.

Vehicle:

no

Details on test solutions:

- Preparation of the stock solution and dilution
The test substance was stirred in M4 medium for about 20 hours at 20 ± 2°C. Undissolved test substance was removed by centrifugation (approximately 20 min at about 17700 G). The nominal concentration of the eluate was 100 mg/I.
- The test substance was tested in the range of concentrations between 12,5 and 100 mg/I. The dilution factor was 2. The test was performed with an aqueous extract (eluate) of the test substance (dilution with with M4 medium).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: STRAUS
- Source: The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory of Ecology of BASF AG in Ludwigshafen.
- Age at study initiation (mean and range, SD): 2 - 24 h ( starting with the 3rd breed of parent animals)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.20 - 3.20 mmol/l

Test temperature:

19.9-20.3

pH:

7.9-8.0

Dissolved oxygen:

8.0-8.7 mg/L

Conductivity:

550 - 650 µS/cm

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 100, 20, 25, 12.5 mg/L
Measured concentrations: < 5, 13.2, 104 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Test tubes (glass) with flat bottom (nominal volume 20 ml)
- Type (delete if not applicable): open
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Number of parallels without animals:
1 (parallel 5) per test concentration and control for measurement of the pH and oxygen content at the beginning of the test. This parallel was thrown away after measurement.
2 per test concentration and control for concentration control analysis.

OTHER TEST CONDITIONS
- Photoperiod: Artificial light, type warm white (e.g: OSRAM L58 W31) day:night rhythm = 16 : 8 h
- Light intensity: About 2 - 7 NE/(m^2•s) at a wave length of 400 - 700 nm
- Measurement of temperature: Continuously during the whole test period in a separate vessel close to the test vessels.
- Measurement of pH and oxygen: After Oh in an additional replicate without daphnids and after 48h in replicate 1 of each tested concentration.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Test parameter: Swimming ability of the test animals; visually after 0, 24 and 48 h

RANGE-FINDING STUDY
- No

Reference substance (positive control):

yes

Remarks:

potassium dichromate

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

Remarks on result:

other: Nominal concentration verified analytically

Key result

Duration:

48 d

Dose descriptor:

EC50

Effect conc.:

147 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: extrapolated value

Remarks:

95% CI: 112 - 240

Details on results:

No immobility of daphnids was observed at test concentrations 12.5 and 20 mg/L during exposure period of 24 hours and 48 hours. One daphnid was observed immobile at 50 mg/L after 48 hours of exposure, and two daphnids were observed immobile at 100 mg/L after 48 hours.

Based on a new dose-response assessment of the available data with the online modelling tool MOSAIC Surv-Standard (MOdeling and StAtistical tools for ecotoxICology), an 48h-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

No immobility was observed in the control.

Results with reference substance (positive control):

The EC50(24h) of the control substance potassium dichromate was 1.30 mg/I.
(Date of the last control experiment: 25 May 1999).

Reported statistics and error estimates:

No statistical evaluation were performed in the original study, because adverse effects were <= 10 % immobilisation at 100 mg/L.

A new curve-fitting assessment was performed with the online modelling tool MOSAIC Surv-Standard (MOdeling and StAtistical tools for ecotoxICology), Laboratoire de Biométrie et Biologie Évolutive Université de Lyon.

Number of mobile Daphnids in the different test concentrations.

Conc.[mg/l]	Parallel 1 [h]			Parallel 2 [h]			Parallel 3 [h]			Parallel 4 [h]			∑ [h]
	0	24	48	0	24	48	0	24	48	0	24	48	24	48
control	5	5	5	5	5	5	5	5	5	5	5	5	20	20
100	5	5	4	5	5	5	5	5	5	5	5	4	20	18
50	5	5	5	5	5	5	5	5	4	5	5	5	20	19
25	5	5	5	5	5	5	5	5	5	5	5	5	20	20
12,5	5	5	5	5	5	5	5	5	5	5	5	5	20	20

Number of test animals per replicate: 5

Number of test animals per concentration: 20

Analytical measurements for test item concentrations

With an analytical recovery rate of > 80% no transformation of the nominal EC-values into the values of the concentration control analysis occurs.

Time [h]	Stocked with daphnids	Minimum [%]	Maximum [%]
0	no	104,0	105,6
48	no	88,0	97,0
48	yes	89,6	97,0

Validity criteria fulfilled:

yes

Remarks:

according to OECD adopted 1984, 2004

Conclusions:

The derived effect concentration 48h-EC50 (Daphnia magna, immobilisation) > 100 mg/L (nominal); 48-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

Executive summary:

The study investigated acute toxicity of 2,3 -Butanediol to aquatic invertebrate Daphnia magna. The study was performed according to OECD guideline 202 (adopted 1984) and in compliance with GLP. The study was performed under static test conditions at the following test concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L. Test concentrations 0 (control), 12.5 and 100 mg/L were analytically verified.

No immobility of daphnids was observed at test concentrations 0 (control), 12.5 and 20 mg/L during exposure period of 24 hours and 48 hours. One daphnid was observed immobile at 50 mg/L after 48 hours of exposure, and two daphnids were observed immobile at 100 mg/L after 48 hours. As this is considered within the acceptable number of immobile daphnids within a valid control according to the guideline, no further assessment of adverse effects were performed for this test within the study. The derived effect concentration is: 48h-EC50 > 100 mg/L was derived.

However, as there is a slight indication of a dose-response effect of immobility with increasing concentrations, a posterior curve fitting was performed with available data using the online modelling tool MOSAIC Surv-Standard (MOdeling and StAtistical tools for ecotoxICology). Based on the new dose-response assessment of MOSAIC Surv-Standard, the 48h-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

The validity criteria of the test guideline (adopted 1984) were fulfilled. Despite of some deficiencies with respect to the updated guideline, the study was considered adequate and reliable for environmental hazard assessment.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please refer to the read-across report, endpoint specific justification.

Reason / purpose for cross-reference:

assessment report

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

Remarks on result:

other: Effect conc. are identical for the submission substance, because target and source substance have the same MW.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

147 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: extrapolated value

Remarks:

Effect conc. are identical for the submission substance, because target and source substance have the same MW.

Validity criteria fulfilled:

yes

Remarks:

according to OECD adopted 1984, 2004

Conclusions:

The derived effect concentration 48h-EC50 (Daphnia magna, immobilisation) > 100 mg/L (nominal); 48-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

Executive summary:

The study used as source investigated acute toxicity (immobility) to aquatic invertebrate Daphnia magna during 48 hours. The study results of the source compound were considered applicable to the target compound, and were used for classification and labelling acc. to Regulation (EC) No 1272/2008. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13.

Description of key information

The derived effect concentration 48h-EC50 (Daphnia magna, immobilisation) > 100 mg/L (nominal); 48-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

147 mg/L

Additional information

No toxicity data concerning respiration inhibition of activated sludge is available for the submission substance. However, adequate and reliable data are reported here for a structural analogue (source substance 2,3 -butanediol). Please also refer to the read-across justification document.

In the available key study, acute toxicity to aquatic invertebrate Daphnia magna was investigated. The study was performed according to OECD guideline 202 (adopted 1984) and in compliance with GLP. No immobility of daphnids was observed at test concentrations 0 (control), 12.5 and 20 mg/L during exposure period of 24 hours and 48 hours. One daphnid was observed immobile at 50 mg/L after 48 hours of exposure, and two daphnids were observed immobile at 100 mg/L after 48 hours. As this is considered within the acceptable number of immobile daphnids within a valid control according to the guideline, no further assessment of adverse effects were performed for this test within the study. The derived effect concentration is: 48h-EC50 > 100 mg/L.

However, as there is a slight indication of a dose-response effect of immobility with increasing concentrations, a posterior curve fitting was performed with available data using the online modelling tool MOSAIC Surv-Standard (MOdeling and StAtistical tools for ecotoxICology). Based on the new dose-response assessment of MOSAIC Surv-Standard, the 48h-EC50 value was estimated (extrapolated) at 147 mg/L (95% CI: 112 - 240).

The validity criteria of the test guideline (adopted 1984) were fulfilled. Despite of some deficiencies with respect to the updated guideline, the study was considered adequate and reliable for environmental hazard assessment.