Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This information is from a document which summarises many investigations on the substance potassium clavulanate, the document reviews the results of many study reports and very little information regarding the methods has been included, which is why a klimisch reliability of 4 has been given.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Reference substance name:
Potassium Clavulanate
IUPAC Name:
Potassium Clavulanate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
dog
Strain:
Beagle
Sex:
not specified

Administration / exposure

Route of administration:
intravenous
Vehicle:
not specified
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
no data
Frequency of treatment:
not stated
Post exposure period:
not stated
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 250, 400, 500 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
no data available
Control animals:
no

Examinations

Examinations:
blood pressure, heartrate were assessed during the study

Results and discussion

Any other information on results incl. tables

Cardiovascular toxicity has been assessed in the anaesthetised beagle dog. A small persistent

fall in blood pressure occurred at the top dosage, with maximal plasma concentrations of 1675 and 1470 micro.g/ml.

Increase In heart rate occurred at Intermediate dose levels. Slight depression of T-waves was seen on infusion of 50 mg/kg (plasma concentrations of BRL.14151 86 and 56 micro.g/ml) and increased to T-wave inversion after a cumulative dose of 400 mg/kg. In a further study in unanaesthetised rats, reversible T-wave changes were observed after 250 mg/kg dosed intravenously, but did not regress after 500 mg/kg intravenously.

Applicant's summary and conclusion

Conclusions:
A small persistent fall in blood pressure occurred at the top dosage, with maximal plasma concentrations of 1675 and 1470 micro.g/ml. Increase In heart rate occurred at Intermediate dose levels.
Executive summary:

Cardiovascular toxicity has been assessed in the anaesthetised beagle dog. A small persistent fall in blood pressure occurred at the top dosage, with maximal plasma concentrations of 1675 and 1470 micro.g/ml. Increase In heart rate occurred at Intermediate dose levels.