Registration Dossier
Registration Dossier
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EC number: 210-323-0 | CAS number: 612-83-9
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- year of publication: 2007
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary source, original data not available
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Series on Testing and Assessment, Number 67: Report of the validation of the uterotrophic bioassay: additional data supporting the test guideline on the uterotrophic bioassay in rodents.
- Author:
- OECD (Organisation for Economic Co-operation and Development)
- Year:
- 2 007
- Bibliographic source:
- ENV/JM/MONO(2007)19 (http://appli1.oecd.org/olis/2007doc.nsf/linkto/env-jm-mono(2007)19; printed 20-12-2008)
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD TG 440
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- 3,3'-dichlorobenzidine dihydrochloride
- EC Number:
- 210-323-0
- EC Name:
- 3,3'-dichlorobenzidine dihydrochloride
- Cas Number:
- 612-83-9
- Molecular formula:
- C12H10Cl2N2.2ClH
- IUPAC Name:
- 3,3'-dichloro-[1,1'-biphenyl]-4,4'-diamine dihydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- immature rats (20 days old at the beginning of the exposure period)
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- 3 times on three consecutive days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
no data
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Observed effects
- hER binding activity (RBA) was 0.000441
- hERalpha agonist activity, PC10 (M): 1.79E-07
Applicant's summary and conclusion
- Conclusions:
- The test substance gave a negative result in the uterotrophic assay regarding estrogenicity and antiestrogenicity. Human estrogen receptor binding activity (RBA) and human estrogen receptor alpha agonist activity were very low (0.000441 and PC 10: 1.79E-07 M, respectively).
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