Registration Dossier

Administrative data

Description of key information

.Beta.-Cyclodextrin is relatively harmless in case of oral, dermal and inhalative administration. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Beta-Cyclodextrin was administered to groups of 10 male and female rats at a limit concentration of 5000 mg/kg bw. No mortality was observed within these groups. In the first hour lower tonicity and hyperpnoea were observed. All animals recovered after 24 h. No other signs of toxcicity were observed. The LD50 of beta-cyclodextrin for rats of both sex was determined to be > 5000 mg/kg bw.

Beta-Cyclodextrin was administered to groups of 10 male and female mice at a limit concentration of 3000 mg/kg bw. No mortality was observed within these groups. In the first hour lower tonicity, somnolentia and hyperpnoea were observed. All animals recovered after 24 h. No other signs of toxcicity were observed. The LD50 of beta-cyclodextrin for mice of both sex was determined to be > 3000 mg/kg bw.

Beta cyclodextzrin (98% pure) was assessed for its dermal toxicity in 5 rats of each sex according to OECD Guideline 402. The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. Under the conditions of the study, single dermal application of the test item to rats at a limit dose of 2000 mg/kg body weight was associated with mild signs of toxicity, but no mortality. Chromodacryorrhea was observed in 2 of 5 female animals and in 1 of 5 male animals. 1 of 5 female animals and 1 of 5 male animals showed a dark discolouration of the right lung. The body weight development of all male and female animals was within the expected range, except for a slight weight loss in 1 out of 5 female animals. Scratches were observed in 2 of 5 female. All signs of irritation were reversible within the observation period, except for 1 of 5 female animals. For acute percutaneous toxicity neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000mg/kg body weight.

Beta-Cyclodextrin was also evaluated in rats in another study according to OECD Guideline No. 402. The test substance was prepared in its original form on a moistened compress at a dose of 2000 mg/kg and then applied to the skin of 10 Sprague-Dawley rats (5 males and 5 females). After 24 hours under a semi-occlusive dressing, residual test substance was removed using a compress saturated with water.

The mortality. general behaviour and body weight gain of the animals were observed for a period of 14 days after the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study.

The general behaviour and body weight gain of the animals were not influenced by the treatment. No deaths occurred at the dose level of 2000 mg/kg. The macroscopic examination revealed no abnormalities in the animals sacrificed at the end of the study.

Under our experimental conditions, the LD 50 of the test substance beta-Cyclodextrin administered by dermal route in rats was higher than or equal to2000 mg/kg.No signs of toxicity were observed at this dose level.

Five young. adult, male and female albino rats (approximately 8 weeks of age) of the Sprague-Dawley derived strain were used to evaluate the inahaltion toxicity of .beta.-cyclodextrin. The study was a limit whole body inhalation study at a nominal concentration of 15.4 mg/l and a gravimetrically measured concentration of 4.9 mg/l. It was performed to a guideline equivalent to OECD 403. The average actual concentration of Beta Cyclodextrin was 32% of the nominal concentration. Adsorption of the test article to chamber surfaces, dermal exposure to the animals and the generation of particle aggregates which do not remain suspended in the test atmosphere, contributed to this difference.. The animals were exposed to the test article for 4 hours. Six minutes were added to the 240 minute exposure period in order to allow the test system to reach 99 percent of the desired concentration (point of equilibration). Food and water were not made available during the exposure period. During the exposure period, the animals were individually housed in wire-mesh cages. Animals were observed twice daily and body weights were recorded periodically throughout the 14-day study period. All animals were subjected to a gross necropsy and examined for lesions and/or abnormalities. No mortality occurred. Nasal discharge was noted in all animals immediately following exposure. Body weight data were just slightly affected. The test article exposure did not exhibit an adverse effect upon body weight gain in males. Weight loss was recorded in one female at days 8 and 15. No lesions or abnormalities were noted during gross necropsy examination. Four-hour whole-body exposure to a dust generated from Beta Cyclodextrin at an average actual concentration of 4.9 mg/L failed to produce mortality in five male and five female Sprague-Dawley rats.

Justification for classification or non-classification

The LC50 under inhalative administration is > 4.9 mg/l and it can be assumed that the LD50 is also > 5.0 mg/l due to lack of mortality in this test. The LD50 of beta-cyclodextrin after oral administration for mice and rats was determined to be > 3000 mg/kg bw and > 5000 mg/kg bw respectively. The LD50 of beta-cyclodextrin after dermal administration for rats was determined to be > 2000 mg/kg bw.