2-Hydroxypropyl-β-cyclodextrine ethers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: comparable to OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

IUPAC Name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: White Powder
- Analytical purity: 89.16%
- Purity test date: 1996-07-11
- Lot/batch No.: 01
- Expiration date of the lot/batch: 1997-03-01
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: received at SLS from Charles River Laboratories, Inc., Portage, Michigan
- Age at study initiation: young adult
- Weight at study initiation: 263g/ 249g m/f
- Fasting period before study: 1 day
- Housing:animals were housed individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 62-73
- Humidity (%): 73
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Auqa dest.

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle (if gavage): day 0: the test article was administered orally as a single dose using a ball tipped stainless steel gavage needle attached to a syringe.

Doses:

2243 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 times (Prefasted Day -1, Days 0, 7, 14)
- Necropsy of survivors performed: yes
- Other examinations performed: euthanized (carbon dioxide inhalation); Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 243 mg/kg bw

Mortality:

Male: 2243 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2243 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No mortality occurred or significant clinical abnormalities.

Gross pathology:

Effects on organs.
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred or significant clinical abnormalities were noted during the limit test.
Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14.

Executive summary:

The short-term oral toxicity and lethality of hydroxypropylated .beta.-cyclodextrin was evaluated in Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose of 2243 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14).

No mortality occurred or significant clinical abnormalities were noted during the limit test.

Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14.

Under the conditions of this test, the acute oral LD50 of hydroxypropylated .beta.-cyclodextrin was estimated to be greater than 2243 mg/kg in the rat.