Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results

Data source

Reference
Reference Type:
publication
Title:
Synthesis and Skeletal Muscle Relaxant Activity of Quaternary Ammonium Salts of Dantrolene and Clodanolene
Author:
ELLIS,. K. 0. , WHITE, Jr., R. L, WRIGHT, G. C.and . WESSELS, F. L
Year:
1980
Bibliographic source:
Journal of Pharmaceutical Sciences Vol. 69. No. 3 (March 1980) pp 327-331

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Direct stimulation of the gastrocnemius muscle in rats was examined.
GLP compliance:
no
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzyltrimethylammonium chloride was purchased from Aldrich Chemical Company. No further details provided.

Test animals

Species:
rat
Strain:
other: TAC:SD/NfBr
Sex:
not specified

Administration / exposure

Route of administration:
intravenous
Vehicle:
other: tetrahydrofurfuryl alcohol
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
No data.
Frequency of treatment:
Rats received a single iv treatment
Post exposure period:
No additional information available.
Doses / concentrations
Remarks:
Doses / Concentrations:
25 mg/kg
Basis:
other: iv administered dose
No. of animals per sex per dose:
No data
Control animals:
not specified

Results and discussion

Details on results:
The maximum percent change in Gastrocnemius Muscle Twitch Response following iv administration of 25 mg/kg benzyltrimethylammonium chloride was 10.1 +/- 1.5.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Conclusions:
The maximum percent change in Gastrocnemius Muscle Twitch Response following iv administration of 25 mg/kg benzyltrimethylammonium chloride was 10.1 +/- 1.5.
Executive summary:

The effect of the test material on muscle was evaluated. The maximum percent change in Gastrocnemius Muscle Twitch Response following iv administration of 25 mg/kg benzyltrimethylammonium chloride was 10.1 +/- 1.5.