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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report with some details lacking

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
no
Principles of method if other than guideline:
Groups of 10 animals per sex were dosed with 1000 mg/kg body weight. The animals were pobserved for 14 days.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
beta-cyclodextrin was used

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals and environmental conditions:
animals had a weight of 150 - 200 g, no other data available

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
water
Details on exposure:
no data available
Doses:
1000 mg/kg body weight.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 according to Litchfiled Wilcoxson

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Remarks on result:
other: none
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Remarks on result:
other: none
Mortality:
Male: 0/10 males administered with 1000 mg/kg bw died during the course of this test.
Female: 0/10 females administered with 1000 mg/kg bw died during the course of this test.
Clinical signs:
Clinical signs were erethism and tonicity as well as hyperpnoea beginning 7 minutes post adminisitration
Body weight:
not observed
Gross pathology:
not reported
Other findings:
not reported

Applicant's summary and conclusion

Conclusions:
The LD50 of beta-cyclodextrin administered to rats subcutaneously was > 1000 mg/kg bw for females and males.