Registration Dossier

Toxicological information

Toxicity to reproduction: other studies

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: determination of reproduction organ weights in a 28 day repeated dose toicity study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD TG 407
Deviations:
yes
Remarks:
14 day recovery period (control and highest dose group=
GLP compliance:
yes
Type of method:
in vivo

Test material

Constituent 1
Reference substance name:
7803-57-8
Cas Number:
7803-57-8
IUPAC Name:
7803-57-8
Constituent 2
Reference substance name:
hydrazine hydrate, 64 %
IUPAC Name:
hydrazine hydrate, 64 %
Details on test material:
IUCLID4 Test substance: other TS: hydrazine monohydrate, purity: 100.15 %

Test animals

Species:
rat
Strain:
other: Crj: CD (SD)IGS
Sex:
male/female
Details on test animals or test system and environmental conditions:
see section 7.5.1

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
see section 7.5.1
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
see section 7.5.1
Frequency of treatment:
see section 7.5.1
Duration of test:
28 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1, 3, 10, 30 mg/kg bw/d
Basis:

No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

open allclose all
Dose descriptor:
dose level:
Effect level:
ca. 30 mg/kg bw/day
Sex:
male
Basis for effect level:
other: significant decreased absolute weight of epididymis
Dose descriptor:
NOAEL
Effect level:
ca. 30 mg/kg bw/day
Sex:
female

Observed effects

absolute weight of epididymides

Any other information on results incl. tables

male rats:

after treatment for 28 days there was a dose related decrease in mean absolute weight of epididymides which

was significant at 30 mg/kg bw; recovery after 14 days

no changes in relative weights

no other effects observed

female rats:

there were no difference in absolute or relative weights of ovaries when compared to the respective controls

Applicant's summary and conclusion