Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 - 19 Dec 1989 and 07 - 10 Sep 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
purity and source of substance not reported, exposure duration 24h instead of 48h
Qualifier:
according to
Guideline:
other: EEC - Directive 79/831, Annex V
GLP compliance:
yes
Test material information:
Composition 1
Analytical monitoring:
yes
Details on sampling:
- Concentrations: one concentration level with 526.5 mg/L of Isopropylchloride and 5.7 mg/L of Tween 80.
- Sampling method: not reported
- Sample storage conditions before analysis: not reported
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 10 g/L Isopropylchloride and 100 mg/L Tween 80 was prepared. The actual test concentrations were achieved by dilution of the stock solution with synthetic water.
- Controls: vehicle control
- Chemical name of vehicle: Tween 80
- Concentration of vehicle in test medium: 10 mg Tween 80/L
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Ircha
- Source: laboratory breed
- Age at study initiation: 6-24 hours
- Method of breeding: laboratory breed. The daphnia were held in 1000 mL glass vessels with synthetic water. Daphnia were fed every 24 h with unicellular green algae and a substitute medium (extract of fish pellets). The holding water was renewed once every 24 h. Holding conditions were as follows: Temperature: 20 ± 2 °C; O2 concentration: at least 80% of air saturation; pH = 7.0 - 8.5; Hardness: 14 °dH; Exposure to light: 16 h daily.
- Feeding during test: none
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Post exposure observation period:
none
Hardness:
14 °dH
Test temperature:
18 ± 1 °C
pH:
7.95 - 8.32
Dissolved oxygen:
8.5 - 9.8 mg/L
Nominal and measured concentrations:
control, 36, 51, 71, 100, 140, 190, 260, 360, and 510 mg/L (nominal)
control, 24, 35, 48, 68, 95, 129, 177, 245, and 347 mg/L (average effective concentration, 68% of the initial test article concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel: 25 mL volumetric cylinder
- Type: Covered with parafilm.
- Material, size, headspace, fill volume: 25 mL volumetric cylinder filled with 10 mL of test solution.
- Aeration: none
- No. of organisms per vessel: 5 animals
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic water according to OECD guideline 203: KCL, CaCl2*2H2O, MgSO4*7H2O, NaHCO3.
- Culture medium different from test medium: Same as test.
- Intervals of water quality measurement: Temperature, O2 concentration and pH values were measured at 0 and 24 h.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark

EFFECT PARAMETERS MEASURED:
- Immobilisation: at 24 h.

VEHICLE CONTROL PERFORMED:
Yes, an additional control group with 10 mg/L of Tween 80 was included.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: serial dilution factor of 1.4

- Range finding study
- Test concentrations: 0.1, 1, 10, 100, 1000 mg/L
- Results used to determine the conditions for the definitive study: Yes, the highest concentration at which no animals were immobilisied (EC0) was 10 mg/L. The lowest concentration at which the immobilisation amounted to 100% (EC100) was 1000 mg/L.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 245 - < 347 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 20% immobility at 245 mg/L and 90% immobility at 347 mg/L. Due to volatility, these values were calculated as 68% of the nominal concentrations of 360 mg/L and 510 mg/L.
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 360 - < 510 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: not reported
- Other biological observations: not reported
- Mortality of control: 0%
- Other adverse effects control: not reported
- Abnormal responses: not reported
Results with reference substance (positive control):
not reported
Reported statistics and error estimates:
Due to the nature of the data, a statistical calculation of the EC50 was not possible. It was more appropriate to state a range for the EC50.

Table 1. Results of the main test. The number of living Daphnia (Σ) and the rate of immobilization (%) in per cent after 24 h are given. After 24 h the EC0 was around 140 mg/L. The EC100 was not detectable, the EC90 was at 510 mg/L. The 5% mortalities observed for the concentration of 51 mg/L and 36 mg/L are not explicable by the influence of the test article.

Conc.

[mg/L]

510

360

260

190

140

100

71

51

36

10.0 Tween 80

Control

Group I

1

4

5

4

5

5

5

5

4

5

5

Group II

1

2

5

5

5

5

5

4

5

5

5

Group III

0

0

5

5

5

5

5

5

5

5

5

Group IV

0

0

4

5

5

5

5

5

5

5

5

Σ

2

16

19

19

20

20

20

19

19

20

20

%

90

20

5

5

0

0

0

5

5

0

0

 

Analytical results:

The measured concentration values were plotted against time, and an exponential decrease was assumed from the corresponding curve. As a mean value for both experiments, the graphical integration yielded an average effective concentration of 68% of the initial test article concentration.

Because of the characteristics of the results for the main test, it was more appropriate to give a range for the 24 h EC50: 360 mg/L<EC50<510 mg/L. These values are based on the initial concentrations of the test article. If the average effective concentration (68% of the initial test article concentration) is used as a basis, the EC50 can be corrected as follows: 245 mg/L<EC50<347 mg/L.

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:
Please refer to the read-across justification document attached to section 13 in IUCLID.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 245 - < 347 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 20% immobility at 245 mg/L and 90% immobility at 347 mg/L. Due to volatility, these values were calculated as 68% of the nominal concentrations of 360 mg/L and 510 mg/L.
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 360 - < 510 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: not reported
- Other biological observations: not reported
- Mortality of control: 0%
- Other adverse effects control: not reported
- Abnormal responses:not reported
Results with reference substance (positive control):
not reported
Reported statistics and error estimates:
Due to the nature of the data, a statistical calculation of the EC50 was not possible. It was more appropriate to state a range for the EC50.
Conclusions:
Since no data on the acute toxicity of CAS 540-54-5 to Daphnia are available a read-across from a supporting substance was conducted. Please refer to the read-across justification document attached to section 13 in IUCLID. Based on the available data an EC50 (24 h) of 245 mg/L < EC50 < 347 mg/L is determined for CAS 540-54-5.

Description of key information

245 < EC50 < 347 mg/L (corrected average effective concentration, OECD 202, D. magna, 24 h)

Key value for chemical safety assessment

Additional information

As no acute study is available for assessing the toxicity of the substance on Daphnia, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related 2 -Chloropropane (CAS 75-29-6) was applied. The read across is justified due to the structural similarity of the analogue substances and similar physico-chemical properties resulting in a similar environmental fate and ecotoxicity profile. Further justification is given in the analogue justification attached to section 13 in IUCLID.

There is one GLP study available investigating the acute toxicity towards aquatic invertebrates of the structural analogue of the test substance in water according to the OECD guideline 202.

In a static test, D. magna were exposed to 9 concentrations of the test substance ranging from 36 – 510 mg/L (nominal) in volumetric cylinders covered by parafilm for 24 h under controlled conditions with a 16 h light/8 h dark cycle. The test solution was obtained by preparing a stock solution containing the test substance and Tween 80, which was then serially diluted with synthetic water. In order to investigate the rate of loss of the test substance from the test medium, a separate experiment was performed with one concentration level (526,5 mg/L test substance and 5.7 mg/L Tween 80) in identical conditions as maintained in the actual test and analytical measurements were performed at regular intervals (from 0 – 71.7 h) by GC. Water quality and immobilization of Daphnia was recorded at 0 and 24 h.

The analytical results of the test substance yielded an average effective concentration of 68% of the initial test article concentration. As a consequence, the effect concentrations were corrected accordingly. After 24 h mortality in the control and vehicle control was 0%. Furthermore, the EC0 was around 140 mg/L, the EC100 was not detectable and the EC90 was at 510 mg/L. 5% mortality was observed for the concentrations of 51 mg/L and 36 mg/L, which was not explicable by the influence of the test article. Due to the nature of the data, a statistical calculation of the EC50 was not possible. It appeared to be more appropriate to state a range, based on the corrected average effective concentration, which amounted to 245 mg/L < EC50 < 347 mg/L.