Cyclohexapentylose

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD guidelines for Testing of Chemicals, no. 401

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexapentylose

EC Number:

233-007-4

EC Name:

Cyclohexapentylose

Cas Number:

10016-20-3

Molecular formula:

C36H60O30

IUPAC Name:

(1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31R,32R,33R,34R,35R,36R,37R,38R,39R,40R,41R,42R)-5,10,15,20,25,30-Hexakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29-dodecaoxahe ptacyclo[26.2.2.23,6.28,11.213,16.218,21.223,26]dotetracontane-31,32,33,34,35,36,37,38,39,40,41,42-dodecol

Details on test material:

designation: .alpha.-cyclodextrin
batch no.: V887
appeareance: white powder
Cas. Reg. no.: 18016-20-3

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young male and female Swiss-outbred mice (Crl: CD) were obtained from a colony, maintained under SPF conditions at the Breeding Centre for Laboratory Animals "Charles River Wiga GmbH", Sulzfeld, F.R. Germany. Upon arrival the mice were checked for signs of ill health and anomalies. The mice were kept under the environmental conditions of the Institute's animal house for an acclimatization period prior to the test. Within each group the mice were individually identified by one of five different V-shaped earmarks.

Administration / exposure

Route of administration:

intravenous

Vehicle:

physiological saline

Doses:

500, 750, 1000 or 2500 mg substance per kg body weight

No. of animals per sex per dose:

2500 mg : 2 animals / sex
1000 mg: 1 animal / sex
750 mg: 5 animals / sex
500: 1/ sex (pre experiment) and 4/ sex

Control animals:

not specified

Details on study design:

The substance was given intravenously by tail vena punction as a solution in sterile saline to male and female mice, in single doses.
The mice were observed frequently for signs of intoxication, during the first 4 hours after treatment and thereafter, at least once daily throughout an observation period of 14 days. The individual body weights of the mice were recorded on day 0, 3, 7 and 14. At the end of the observation period, the mice were killed for macroscopic examination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: intravenous LD50

Effect level:

> 750 - < 1 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the two highest dose groups (2500 and 1000 mg/kg), one male and one female of the 750 mg/kg group and three females of
the 500 mg/kg group died within a few days after treatment.

Clinical signs:

Dose-related signs of intoxication were observed within one hour to a few days after treatment in all dose groups, such as sluggishness and piloerection. Survivors generally showed decreased growth rate however, the animals recovered and looked quite healthy again at the end of the observatio period.

Body weight:

no data available

Gross pathology:

At autopsy a dark spleen was observed in all animals of the highest dose group of 2500 mg/kg and moreover, in males of the same dose group a yellowish mucous in the abdomen was observed.

Other findings:

See Gross pathology. Marcroscopic examination of all other animals that were found dead and of survivors at the end of the observation period did not reveal treatment-related gross alterations.

Applicant's summary and conclusion

Conclusions:

From the data presented it is concluded that the intravenous LD50 of .alpha.-cyclodextrin is between 750 and 1000 mg/kg body weight.

Executive summary:

The acute intravenous toxicity of .alpha.-cyclodextrin was determined in mice.

The test substance was given by intravenous injection as a solution in sterile saline to male and female mice in single doses of 500, 750, 1000 or 2500 mg substance per kg body weight.

The main test consisted of three experiments.

 

Dose-related signs of intoxication were observed within one hour to a few days after treatment in all dose groups, such as sluggishness and piloerection. All animals of the two highest dose groups (2500 and 1000 mg/kg), one male and one female of the 750 mg/kg group and three females of the 500 mg/kg group died within a few days after treatment. Survivors generally showed decreased growth rate however, the animals recovered and looked quite healthy again at the end of the observation period. At autopsy a dark spleen was observed in all animals of the highest dose group of 2500 mg/kg and moreover, in males of the same dose group a yellowish mucous in the abdomen was observed. Marcroscopic examination of all other animals that were found dead and of survivors at the end of the observation period did not reveal treatment-related gross alterations.

 

From the data presented it is concluded that the intravenous LD50 of .alpha.-cyclodextrin can be expected between 750 and 1000 mg/kg body weight.