Registration Dossier
Registration Dossier
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EC number: 203-966-3 | CAS number: 112-39-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 May - 26 May 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions; analytical purity data on test item not given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl palmitate
- EC Number:
- 203-966-3
- EC Name:
- Methyl palmitate
- Cas Number:
- 112-39-0
- Molecular formula:
- C17H34O2
- IUPAC Name:
- methyl palmitate
- Details on test material:
- - Name of test material (as cited in study report): Palmitinsäuremethylester
- Physical state: solid, pasty, white
- Analytical purity: not given
- Stability under test conditions: stable in arachidis oil, DAB 9
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 175 g (males), 164 g (females)
- Housing: groups of 5 animals per cage, in Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet: pelleted Altromin Maintainance diet 1314 (Altromin GmbH, 4937 Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 43-75
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs twice daily; body weight on day -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes, macroscopic examination of all external orifices and organs in the thoracic and visceral cavities.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Gross pathology revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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