2-Hydroxypropyl-β-cyclodextrine ethers

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity 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): .beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
- 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):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Beldt's Aquarium. Inc., Hazelwood, Missouri
- Length at study initiation (length definition, mean, range and SD): 34 (± 1.9) mm (Control mean), range 30 to 38 mm, SD)
- Weight at study initiation (mean and range, SD): 0.365g (Control mean), +/- 0.0678 (SD)
- Food type: newly hatched brine shrimp or a commercially available fish food
- Frequency: daily

ACCLIMATION
- Acclimation period: 14 days prior to the definitive test (acclimated to the test dilution water and test temperature approximately 72h)
- Type and amount of food: none
QUARANTINE (wild caught)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

140 mg/L as CaCO3

Test temperature:

22 ± 2 °C

pH:

8.04

Dissolved oxygen:

5.1 to 6.0 mg/L, (62 and 73% saturation)

Salinity:

no data

Nominal and measured concentrations:

Nominal C.: Control (0.0) and 1000 mg/L
Mean Measured C.: 0.0 and 1131 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: jars
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: widemouth glass, 18L, 15 L
- Aeration: 24 hours of the defInitive test
- Type of flow-through (e.g. peristaltic or proportional diluter): Gentle aeration was provided by slowly bubbling air through a glass pipet.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: 0.243 g/L (control group)

TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: 1.21 mg/L
- Metals: 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: 160 mg/L as CaCO3
- Conductivity: 350 µmhos/cm

OTHER TEST CONDITIONS
- Photoperiod: 16-hour daylight with 30-minute simulated dawn and dusk periods

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: control (0.0) and 1000 mg/L

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 131 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 1 131 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks:

, behaviour

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Any other information on results incl. tables

Sublethal observations / clinical signs:

Measured Concentrations of hydroxypropylated .beta.-cyclodextrin during the Acute Static Toxicity Test with Zebrafish (Brachydanio rerio):

Sample	Nominal Conc. (mg/L)	Measured Conc. (Mg/L)	Mean Measured (mg/L)	Percent Nominal
0 hour
Control	---	0	---	---
Test Level	1000	1146	---	115
Spike	1100	1177	---	107
96 hours
Control A	---	0	---	---
Control B	---	0	---	---
Test Level A	1000	1122	1115	112
Test Level B	1000	1108
Spike	929	968	---	104
Mean Test Level ± SD = 1131 ± 22 mg/L; Mean Spike ± SD = 106 ± 2.1 %

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The nominal test concentration of 1000 mg/L hydroxypropylated .beta.-cyclodextrin exposed to Zebrafish (Brachydanio rerio) during the conduct of the 96-hour static acute test had a mean measured test concentration of 1131 mg/L, which was 113% of the nominal concentration. No mortality and/or adverse effects were observed during the test. Therefore, the 96-hour LC50 for Zebrafish (Brachydanio rerio) exposed to hydroxypropylated .beta.-cyclodextrin was estimated to be > 1131 mg/L. In addition, the 96-hour no-observed effect concentration (NOEC) was > 1131 mg/L, based on the mean measured concentration. A 96-hour dose response slope could not be determined since the study was conducted as a single concentration limit test.

Executive summary:

The objective of this test was to estimate the toxicity of hydroxypropylated .beta.-cyclodextrin to Zebrafish (Brachydanio rerio) under static conditions following the procedures outlined in ABC Protocol No. EEC C1 for ABC Study Number 43997. The test was designed to yield LC50 values following 24, 48, 72, and 96 hours of exposure and a no-observed effect concentration (NOEC), if possible. The definitive test was conducted from June 23, 1997, to June 27, 1997.

The definitive study was conducted as a limit test using the nominal test concentration of 1000 mg/L of hydroxypropylated .beta.-cyclodextrin along with a control. Twenty fish (ten fish in each of the two replicates) were exposed to the control and test concentration. Samples for analytical confirmation were collected from each test replicate at 0 and 96 hours during the definitive test. The mean measured test concentration for samples analyzed at 0 and 96 hours was 1131 mg/L, representing 113% of the 1000 mg/L nominal test concentration.

Water quality parameters of temperature, dissolved oxygen, and pH were measured throughout the study and were within acceptable limits. The temperature of the test solutions ranged from 22.4 to 23.4°C and the dissolved oxygen levels ranged from 5.1 to 8.2 mg/L. The pH of the test solutions ranged from 7.8 to 8.4.

All fish in the control and 1000 mg/L nominal test concentration were normal during the study with no observed abnormal effects or mortality. The 24-, 48-, 72-, and 96-hour LC50 values for hydroxypropylated .beta.-cyclodextrin to Zebrafish (Brachydanio rerio) were all estimated to be greater than the mean measured test concentration of 1131 mg/L. The 96-hour NOEC was determined to be >= 1131 mg/L which was based on the lack of abnormal effects and mortality at this concentration. A slope of the 96-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.