Registration Dossier
Registration Dossier
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EC number: 248-471-3 | CAS number: 27458-94-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- The absence of testicular atrophy and in vivo and in vitro effects on hepatocyte morphology and peroxisomal enzyme activities in male rats following the administration of several alkanols.
- Author:
- Rhodes T, Soames MD, Stonard MG, Simpson AJ, and Combe CR
- Year:
- 1 984
- Bibliographic source:
- Toxicology Letters, 21:103-109
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 14 day study, single dose.
- Principles of method if other than guideline:
- Animals received test material by oral gavage daily for 14 days.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Isononyl alcohol
- EC Number:
- 248-471-3
- EC Name:
- Isononyl alcohol
- Cas Number:
- 27458-94-2
- Molecular formula:
- C9H20O
- IUPAC Name:
- 3,5,5-trimethylhexan-1-ol
- Details on test material:
- No information.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Not data provided.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- Animals received a dose level equivalent of 1 mmol/kg/day dissolved in polyethylene glycol 300 (10 ml/kg/day)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Once daily
- No. of animals per sex per dose:
- No data provided.
- Details on study design:
- No data provided.
- Positive control:
- No data provided.
Examinations
- Observations and examinations performed and frequency:
- The liver was removed for histopathological analysis, analysis of catalase, and CN-insensitive palmitoyl CoA oxidation. Testicular weight was also determined.
- Sacrifice and pathology:
- Morphology of the liver.
- Statistics:
- No data analyzed
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 144 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: All endpoints examined.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
In a two-week oral study, five male rats were dosed by oral gavage with 144 mg/kg bw/day of isononanol. In the control group, ten animals received the vehicle, PEG (polyethylene glycol) 300, daily for 14 days. Animals were sacrificed after 14 days and blood was analyzed for plasma cholesterol and triglycerides. The liver was removed for histopathological analysis, analysis of catalase, and CN-insensitive palmitoyl CoA oxidation. Testicular weight was also determined. Isononanol did not significantly influence bodyweight gain, liver to bodyweight ratio, testis to bodyweight ratio, or palmitoyl CoA oxidase activity. It is concluded that the NOAEL is 144 mg/kg/day.
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