Registration Dossier
Registration Dossier
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EC number: 203-751-4 | CAS number: 110-27-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Version / remarks:
- no guideline available
- Principles of method if other than guideline:
- dietary administration of isopropyl myristate for 14 days in rats, results should be used for a subsequent 90 day sub-chronic study in rats
- GLP compliance:
- not specified
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Isopropyl myristate supplied by Allan Chemical Corporation, Fort Lee, New Jersey (lot "070102805)
Test animals
- Species:
- rat
- Strain:
- other: F344/DUCRL
- Details on species / strain selection:
- 8 weeks old, healthy, females nulliparous and non-pregnant, supplied by Charles River Laboratories Inc. (Kingston, New York)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing: One rat per cage, stainless steel cages with a wire mesh floor and suspended above absorbent paper, temperature 22+/- 1°C, humidity. 40-70%, air changes: 12-15 times/hour, photoperiod: 12 hours light/dark
Feed and water: LabDiet Certified Rodent Diet, municipal water ad libitum
Identification by subcutaneously implanted transponders
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- diets mixed weekly and dietary concentrations adjusted basesd upon the recent body weight and feed consumption data
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 14 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 rats/sex/dose = 60 rats on study
- Control animals:
- yes
- yes, concurrent no treatment
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- daily: cage-side examination, twice weekly: body weight, feed consumption, weekly: clinical observations (hand-held), calculation of test material intake, statistics
- Sacrifice and pathology:
- all animals killed on day 15 of the experiment
- Other examinations:
- no
- Statistics:
- mean body weight and body weight gain, feed consumption, test material intake
Results and discussion
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
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable because of methodological limitations
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, isopropyl myristate was palatable to F344/DuCRL rats given up to 1000 mg/kg bw/ day for 14 days.
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