Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The paper by Ohuchida et al. was published 1994 in a Japanese journal as part of a series of publications on Tazobactam. Only the summary and the Tables are provided in English. Therefore the evaluation restricts to the English parts of the paper. The report provides in the summary and the relevant Tables 8 and 9 only few details on the method used. Missing information, which might appear in the Japanese text, are: Purity of the test substance; evidence of the compliance with GLP; etc.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity tests of tazobactam/piperacillin, tazobactam and piperacillin.
Author:
Ohuchida A; Taniguti A; Kouchi Y; Maeda Y; Kashihara A; Omae S
Year:
1994
Bibliographic source:
J Toxicol Sci 1994 Oct; Vol 19, Suppl 2: pp 263-80.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male

Administration / exposure

Route of administration:
intravenous
Frequency of treatment:
once
Post exposure period:
24, 48 and 72 h in the pilot test.
48 h in the definitive test.
Doses / concentrations
Remarks:
Doses / Concentrations:
625 to 5000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5 males per dose.
Control animals:
yes
Positive control(s):
MMC,; i.p. administration of 2 mg/kg; analysis 24 h after administration.

Examinations

Tissues and cell types examined:
Femoral marrow was analysed for red blood cells, polychromatic erythrocytes, micronuclei containing polychromatic erythrocytes.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Remarks:
only slight effect
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The frequency of micronuclei containing polychromatic erythrocytes was between 0.0.2 and 0.17 %.

Applicant's summary and conclusion

Conclusions:
Tazobactam is considered not to have an in vivo mutagenic potential, in this test.