Registration Dossier
Registration Dossier
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EC number: 294-582-5 | CAS number: 91744-20-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- May 8th, 1990 - May 22nd, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance 91744-13-7. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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, C14-18 and C16-22-unsatd. mono- and di-
- EC Number:
- 294-574-1
- EC Name:
- Glycerides, C14-18 and C16-22-unsatd. mono- and di-
- Cas Number:
- 91744-13-7
- IUPAC Name:
- 91744-13-7
- Reference substance name:
- Glyceride, C14-18 and C16-22 unsaturated, mono- and di-
- IUPAC Name:
- Glyceride, C14-18 and C16-22 unsaturated, mono- and di-
- Details on test material:
- - Name of test material (as cited in study report): Glycerides, C14-18 and C16-22, unsaturated, Mono- and Di-
- Batch No.: 0189-0-040
- Physical state: brownish fluid
- Analytical purity: 100 % a.s.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- 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: males 180 g, females 161 g (mean values)
- Fasting period before study: 16 hours
- Housing: 5 per cage in Makrolon 3 cages
- Diet (e.g. ad libitum): Altromin Diet 1324, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: CMC (carboxymethyl cellulose, 1%) + Cremophor (0.5 %) in aqua dest.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % (g/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/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: twice a day
- Frequency of weighing: on days 0, 2, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: rat
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- No treatment related abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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