Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
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:
- 1979-05-07 to 1979-08-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. Restriction: No organ weight determination
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- Method: Sub-chronic Repeated Dose Toxicity, U.S. NTP
- GLP compliance:
- not specified
- Type of method:
- in vivo
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
- Reference substance name:
- Isophorone
- IUPAC Name:
- Isophorone
- Details on test material:
- Leidy Chemical Corporation, 97 % pure, 0.3 % water
- purity and identity analyses were conducted at Midwest Research Institute (Kansas City, MO)
- isophorone test material was stored at 4°C
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Fischer 344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Indianapolis
- Age at study initiation: 8 weeks
- Diet: ad libitum. Purina Lab Chow
- Water: ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 - 24 °C
- Humidity (%): not monitored
- Air changes (per hr): 18-20 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours/day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- ADMINISTRATION / EXPOSURE
- Duration of test/exposure: 5days/week, 13 weeks
- Vehicle: corn oil
- Total volume applied: 1 ml
- Isophorone was added to corn oil in a graduated cylinder. Dose mixtures were prepared by further diluting this stock solution with corn oil to the
appropriate concentrations. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- All chemical/vehicle analyses were performed by gas chromatography.
Isophorone in corn-oil was found to be stable for 7 days at room temperature. - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
- Duration of test:
- 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
62.5, 125, 250, 500, or 1000 mg/kg bw d
Basis:
other: nominal (gavage)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Details of this study are described in chapter 7.5.1.
- Histopathological examinations in reproductive organs were performed: mammary gland, seminal vesicles, prostate/testes or ovaries/uterus.
- Post-exposure period: none - Statistics:
- STATISTICAL METHODS:
Survival, body weight, dose-related effects are statistically evaluated.
Results and discussion
Effect levels
- Dose descriptor:
- other: NOAEL (reproduction)
- Effect level:
- >= 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: no changes in reproductive organs
Observed effects
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Conclusions:
- In this subchronic oral gavage study male and female Fischer rats were administered 0, 62.5, 125, 250, 500 and 1000 mg isophorone/kg bw/day in a 13 week investigation. No changes were observed in histopathological examinations of the reproduction organs.
- Executive summary:
The histological examinations of the reproductive organs of male and female Fischer 344 rats (mammary gland, seminal vesicle, prostate/testis or ovary/uterus) treated orally with up to 1000 mg isophorone/kg bw for 13 weeks did not reveal any adverse effects after macroscopic and microscopic examination.
Under the conditions of this study, the No-Observed-Adverse-Effect-Level (NOAEL, reproduction) is considered to be >= 1000 mg isophorone/kg bw/day for male and female rats.
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