Registration Dossier
Registration Dossier
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EC number: 205-371-4 | CAS number: 139-66-2
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from HSDB
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Reproductive developmental toxicity study of 1,1-Diphenylhydrazine in mice
- Author:
- Hazardous Substances Data Bank
- Year:
- 2 004
- Bibliographic source:
- Hazardous Substances Data Bank (HSDB), Reviewed by SRP on 9/16/2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Reproductive / Developmental Toxicity Test of 1,1-Diphenylhydrazine by Oral Administration in mice
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,1-Diphenylhydrazine
- Cas Number:
- 530-50-7
- Molecular formula:
- C12H12N2
- IUPAC Name:
- 1,1-Diphenylhydrazine
- Details on test material:
- - Name of test material (as cited in study report): 1,1-Diphenylhydrazine
- Molecular formula (if other than submission substance): C12H12N2
- Molecular weight (if other than submission substance): 184.241 g/mole
- Substance type: Organic
- Physical state: Yellow crystals
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1,1-Diphenylhydrazine
- Molecular formula (if other than submission substance): C12H12N2
- Molecular weight (if other than submission substance): 184.241 g/mole
- Substance type: Organic
- Physical state: Yellow crystals
Test animals
- Species:
- mouse
- Strain:
- ICR
- Remarks:
- SIM
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Remarks on MMAD:
- Not specified
- Vehicle:
- not specified
- Details on exposure:
- Not specified
- Details on mating procedure:
- - Any other deviations from standard protocol: Timed-pregnant female were used
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- days 8-12
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 525 mg/kg bw/day
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Body weight was examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Viability, body weight and stillborns were examined.
- Postmortem examinations (parental animals):
- Uteri were examined
- Postmortem examinations (offspring):
- Not specified
- Statistics:
- Not specified
- Reproductive indices:
- Progeny counts or number of resorptions was examined.
- Offspring viability indices:
- Yes, on 0 and 2 day of postpartum were recorded
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- When treated with 525 mg/kg bw, 2 mice died
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant effect on body weight of female mice was observed as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 525 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- body weight and weight gain
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on viability of pups on day 0 and 2 were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups on day 0 and 2 were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 525 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 525 mg/kg bw for P and F1 generation when ICR/SIM female mice were treated with 1,1-Diphenylhydrazine orally by gavage on gestation days 8-12.
- Executive summary:
In a Reproductive / Developmental Toxicity Test, ICR/SIM female mice were treated with1,1-Diphenylhydrazinein the concentration of 0 and 525 mg/kg/day orally by gavage on gestation days 8-12. 2 mice died at 525 mg/kg bw.No significant effect on body weight of female mice was observed as compared to control. Similarly, No effect on Progeny counts or number of resorptions were observed in treated mice as compared to control. In addition, No effect on viability and body weight of pups on day 0 and 2 were observed as compared to control.Therefore, NOAEL was considered to be 525 mg/kg bw for P and F1 generation when ICR/SIM female mice were treated with1,1-Diphenylhydrazine orally by gavage on gestation days 8-12.
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