Registration Dossier
Registration Dossier
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EC number: 947-398-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-03-25 to 1996-04-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Glyceryl Citrate/Lactate/Linoleate/Oleate
- IUPAC Name:
- Glyceryl Citrate/Lactate/Linoleate/Oleate
- Reference substance name:
- Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
- EC Number:
- 294-585-1
- EC Name:
- Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts
- Cas Number:
- 91744-23-9
- IUPAC Name:
- 91744-23-9
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Substance type: product
- Physical state: liquid
- Stability under test conditions: > 1 year
- Storage condition of test material: at room temperatures in the dark
- Manufacture date: May 1995
- Lot/batch No.: 505024
- Expiration date of the lot/batch: not earlier than May 1996
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 146 - 161 g (male); 130 - 142 g (female)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet: R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.004 cm³/kg
- 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: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes - Statistics:
- no statistics performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/10 animals
- Clinical signs:
- none
- Body weight:
- normal body weight gain of all animals
- Gross pathology:
- no findings
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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