2-Hydroxypropyl-β-cyclodextrine ethers

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

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

Test material information

Constituent 1

Reference substance name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

IUPAC Name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

Constituent 2

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:

5,10,15,25-tetrakis(hydroxymethyl)-40,44,47,49-tetrakis(2-hydroxypropoxy)-20,30,35-tris[(2-hydroxypropoxy)methyl]-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2³,⁶.2⁸,¹¹.2¹³,¹⁶.2¹⁸,²¹.2²³,²⁶.2²⁸,³¹]nonatetracontane-36,37,38,39,41,42,43,45,46,48-decol

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 concentrations

Effect concentrations 1

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

Effect concentrations 2

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.