Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The paper 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 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.

Data source

Reference
Reference Type:
publication
Title:
Reproductive and developmental toxicity of Tazobactam/Piperacillin or Tazobactam
Author:
Sato T, Hoberman AM, Christian MS
Year:
1994
Bibliographic source:
J Toxicol Sci 19 Suppl II (1994) 233-247

Materials and methods

Principles of method if other than guideline:
Peri- and postnatal study.
GLP compliance:
not specified
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Daily dosing from day 17 of pregnancy to day 21 of lactation.
Frequency of treatment:
Daily doses were divided in two parts.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Dose / conc.:
40 mg/kg bw/day
Dose / conc.:
320 mg/kg bw/day
Dose / conc.:
1 280 mg/kg bw/day
No. of animals per sex per dose:
22 dams.
Control animals:
yes

Results and discussion

Observed effects

Maternal toxicity: Decreased food consumption in all dosage groups during perinatal period. Body weight gain: Decrease at 1280 mg/kg. Increase in stillbirths at 1280 mg/kg.
Lactation: Decreased pup weight at 320 and 1280 mg/kg.
Post weaning period: Decreased pup weight at 1280 mg/kg.
No other effects in the F1 generation.

Applicant's summary and conclusion

Conclusions:
Conclusion: Peri- and postnatal development and growth and development of offsprings were affected only at the mid and high dose that caused maternal toxicity.
NOELdams is <40 mg/kg/day.
NOELoffsprings is 40 mg/kg/day.
Executive summary:

Conclusion: Peri- and postnatal development and growth and development of offsprings were affected only at the mid and high dose that caused maternal toxicity.

NOELdams is <40 mg/kg/day.

NOELoffsprings is 40 mg/kg/day.