Registration Dossier
Registration Dossier
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EC number: 231-493-2 | CAS number: 7585-39-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Results reported with some details lacking
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- other procedure
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cycloheptapentylose
- EC Number:
- 231-493-2
- EC Name:
- Cycloheptapentylose
- Cas Number:
- 7585-39-9
- Molecular formula:
- C42H70O35
- IUPAC Name:
- 5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2~3,6~.2~8,11~.2~13,16~.2~18,21~.2~23,26~.2~28,31~]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol (non-preferred name)
- Details on test material:
- beta-Cyclodextrin, no other data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- animals had a weight of 150 - 200 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- dosed as a suspension
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- dosed animals were observed for 24 hours
- Statistics:
- LD50 according to Litchfiled Wilcoxson
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality observed
- Mortality:
- no mortality was observed
- Clinical signs:
- other: lower tonicity and hyperpnoea were observed within the first hour. The animals recovered after 24 h.
- Gross pathology:
- no signs observed
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Beta-cyclodextrin is practically nontoxic if administered orally to rats.
- Executive summary:
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 was determined to be > 5000 mg/kg bw.
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