Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
Toxicity to reproduction: other studies
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:
- 2 003
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
- Reference substance name:
- hydrazine monohydrate
- Cas Number:
- 7803-57-8
- Molecular formula:
- H4N2*H2O
- IUPAC Name:
- hydrazine monohydrate
- 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 %
Constituent 1
Constituent 2
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
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
