.alpha.-Cyclodextrin, 2-hydroxypropyl ethers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-05-16 to 2002-08-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cavasol W6 HP

IUPAC Name:

Cavasol W6 HP

Details on test material:

- Name of test material (as cited in study report): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: males 153 - 168 g; females 140 - 152 g
- Fasting period before study: overnight (max. 20 hours
- Housing: standard laboratory conditions; groups of three animals in Makrolon type-4 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not used

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 male/3 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: at periodic intervals on the day 1 and once daily during day 2-15 examination for clinical signs/mortality; body weights were recorded on day 1 before administration and on days 8 and 15
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, mortality, body weights, necropsy

Statistics:

not possible, limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality has been observed.

Clinical signs:

other: No clinical signs have been observed.

Gross pathology:

No findings noted.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.

Executive summary:

A group of three male and five female Wistar rats was treated with Cavsaol W6 HP at 2000 mg/kg by oral gavage. No deaths occurred during the study. General signs of toxicity were not observed. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.