Registration Dossier
Registration Dossier
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EC number: 286-490-9 | CAS number: 85251-77-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 11th, 1999 - March 12th, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono- and di-
- EC Number:
- 286-490-9
- EC Name:
- Glycerides, C16-18 mono- and di-
- Cas Number:
- 85251-77-0
- Molecular formula:
- C19H38O4; C21H42O4; C35H68O5; C39H76O5
- IUPAC Name:
- Glycerides, C16-18 mono- and di-
- Details on test material:
- - Name of test material (as cited in study report): Glyceryl Palmitostearate
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: August 1st, 2000
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat Ico: OFA.SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA-CREDO, Cedex, France.
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: males: 163 - 172 g, females 138 - 149 g
- Fasting period before study: overnight
- Housing: up to 5 in polycarbonate cages
- Diet (e.g. ad libitum): pelleted complete diet, Usine d'Alimentation Rationnelle, France.
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): min 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % (w/w)
- Lot/batch no. (if required): A28557/1
- Purity: pure
Test substance preparation was administered within 4 hours of preparation.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg
- 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: 15 min, 1 h, 2 h and 4 h after administration. Thereafter daily.
- Frequeny of weighing: day -1, immediately before administration and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: rat
- Mortality:
- None.
- Clinical signs:
- other: None.
- Gross pathology:
- No macroscopic abnormalities observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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