Registration Dossier

Diss Factsheets

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

Constituent 1
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
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:
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.