Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-126-0 | CAS number: 78-59-1
Endocrine disrupter mammalian screening – in vivo (level 3)
Administrative data
- Endpoint:
- endocrine disrupter mammalian screening – in vivo
- Remarks:
- Hershberger Assay
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- EDSP Weight of Evidence Conclusions on the Tier 1 Screening Assays for the List 1 Chemicals
- Author:
- US EPA
- Year:
- 2 015
Materials and methods
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Details on test material:
- Purity ≥ 97%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- - 55-d old animals
- Sex:
- male
- State:
- castrated male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 10 d
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 800 mg/kg bw/day
- No. of animals per sex per dose:
- 7
- Control animals:
- yes, concurrent vehicle
- Positive control:
- seven castrated male rats dosed daily with testosterone propionate (TP) in corn oil at 0.4 mg/kg/day via subcutaneous (s.c.) injection
Examinations
- Observations and examinations performed and frequency:
- - body weights and body weight gains
- food consumption
- serum hormone concentrations - Sacrifice and pathology:
- - adrenals, kidneys, and liver were weighed and macroscopically examined
Results and discussion
- Endocrine disrupting potential:
- negative
- Maximum tolerated dose level exceeded:
- no
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Clinical biochemistry findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- - Liver weights were increased (p≤0.05) by 27-28% at 400 mg/kg/day and by 32–34% at 800 mg/kg/day
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
Any other information on results incl. tables
The test substance was negative for androgenicity and anti-androgenicity in the Hershberger assay.
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.
