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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
IUPAC Name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
Constituent 2
Chemical structure
Reference substance name:
-
EC Number:
420-920-1
EC Name:
-
Cas Number:
128446-35-5
Molecular formula:
Hill formula: (C42H70-nO35)(C3H7O)n; n(mittel)=5,25
IUPAC Name:
2-Hydroxypropyl-.beta.-cyclodextrine ethers
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): hydroxypropylated .beta.-cyclodextrin
- Physical state: white solid powder
- Analytical purity: 89.16%
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: ABC Laboratories' in-house culture
- Age at study initiation (mean and range, SD): Neonates (< 24 hours old)
- Feeding during test: no
- Food type: a suspension of at least one algae species (during holding period): Selenastrum capricomutum and/or Ankistrodesmus falcatus
- Amount: one
- Frequency: once a day

ACCLIMATION
Since the culturing and testing parameters of temperature, dilution water, and lighting were the same, no acclimation period was necessary.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
144 mg/L as CaCO3
Test temperature:
21°C
pH:
8.43
Dissolved oxygen:
7.7-8.2 mg/L
Salinity:
no data
Nominal and measured concentrations:
Nominal Test Concentrations: Control (0.0) and 1000 mg/L
Mean Measured Concentrations: Control (0.0) and 1084 mg/L
Details on test conditions:
TEST SYSTEM
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: no greater than one daphnid per 2 mL of dilution water at any time

TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: 0.0 mg/L
- Metals in mg/L: Aluminium 0.053, Cadmium <0.00008, Chromium 0.00087, Cobalt <0.0055, Copper <0.0038, Iron 0.0086, Lead <0.0012, Mercury 0.000051, Nickel <0.0054, Silver <0.00018, Zinc 0.0171
- Alkalinity: 154 mg/L as CaCO3
- Conductivity: 340 µmhos/cm
- Intervals of water quality measurement: weekly

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16-hour light and 8-hour dark
- Light intensity: 55 to 57 footcandles

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: Nominal Test Concentrations: Control (0.0) and 1000 mg/L; Mean Measured Concentrations: Control (0.0) and 1084 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 1 084 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 1 084 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
behaviour
Details on results:
- Behavioural abnormalities: no
- Mortality of control: no
- Other adverse effects control: no

Any other information on results incl. tables

Mean Measured Concentrations of hydroxypropylated .beta.-cyclodextrin during the Acute Static Toxicity Test with Daphnia magna:

Sample

Nominal Conc. (mg/L)

Measured Conc. (mg/L)

Percent Nominal

0 hour

 

 

 

Control

---

0

---

Test Level

1000

1091

---

Spike

972

1028

106

48 hours

 

 

 

Control

---

0

---

Test Level

1000

1077

108

Spike

1000

1063

106

Mean Test Level ± SD = 1084 ± 9.9 mg/L; Mean Spike ± SD = 106 ± 0 %

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The nominal test concentration of 1000 mg/L hydroxypropylated .beta.-cyclodextrin exposed to Daphnia magna during the conduct of the 48-hour static acute test had a mean measured test concentration of 1084 mg/L, which was 108%of the nominal concentration. No immobilization and/or adverse effects were observed during the test. Therefore, the 48-hour EC50 for Daphnia magna exposed to hydroxypropylated .beta.-cyclodextrin was estimated to be > 1084 mg/L. In addition the 48-hour no-observed effect concentration (NOEC) was > 1084 mg/L, based on the mean measured concentration. A 48-hour dose response slope could not be determined since the study was conducted as a single concentration limit test.
Executive summary:

 The test article, hydroxypropylated .beta.-cyclodextrin , was tested in Daphnia magna equivalent to the OECD Guideline Study 202.

The primary objective of this study was to estimate the acute toxicity of hydroxypropylated .beta.-cyclodextrin to Daphnia magna under static conditions. The test was designed to yield EC50 values following 24 and 48 hours of exposure and a no-observed effect concentration (NOEC), if possible. The definitive test was conducted from June 10, 1997, to June 12, 1997.

The definitive study was conducted as a limit test using the nominal test concentration of 1000 mg/L of hydroxypropylated .beta.-cyclodextrinalong with a control. Twenty Daphnia magna (five daphnids in each of the four replicates) were exposed to the control and test concentration. Samples for analytical confirmation were collected from each parent solution at 0 hour and from each replicate at 48 hours of the definitive test. The mean measured test concentration for samples analyzed at 0 and 48 hours was 1084 mg/L, representing 108% of the 1000 mg/L nominal test concentration.

Water quality parameters of temperature, dissolved oxygen, and pH were measured 0 and 48 hours of the definitive study and were within acceptable limits. The temperature of the test solutions ranged from 20.9 to 21.3°C and the dissolved oxygen levels ranged from 7.7 to 8.2 mg/L. The pH of the test solutions ranged from 8.2 to 8.4.

All daphnids in the control and 1000 mg/L nominal test concentration were normal during the study with no observed abnormal effects or immobilization. The 24- and 48-hour EC50 values for hydroxypropylated .beta.-cyclodextrin to Daphnia magna were all estimated to be greater than the mean measured test concentration of 1084 mg/L. The 48-hour NOEC was determined to be >=1084 mg/L, which was based on the lack of abnormal effects and immobilization at this concentration. A slope of the 48-hour dose-response line could not be calculated since the study was conducted as a limit test. All results were based on the mean measured concentration.