Registration Dossier
Registration Dossier
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EC number: 292-769-6 | CAS number: 90990-08-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
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:
- Fatty acids, C8-18
- EC Number:
- 292-769-6
- EC Name:
- Fatty acids, C8-18
- Cas Number:
- 90990-08-2
- Molecular formula:
- C8H16O2 - C18H36O2
- IUPAC Name:
- Fatty Acids C8-18
- Details on test material:
- - Name of test material (as cited in study report): Carbonsäure Edenor K 8-18 (Kokosölfettsäure C 8 - 18)
- Physical state: solid, white
- Analytical purity: no data
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, Hannover, Germany
- Weight at study initiation: mean 153 g (males), 139 g (females)
- Fasting period before study: 18 h, but water ad libitum
- Housing: in groups of 5/sex in Makrolon Type III cages
- Diet: standard laboratory diet (Altromin Haltungsdiät für Ratten); ad libitum
- Water: water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw - Doses:
- 5000 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: observations immediately and 1, 4 and 24 hours after dosing, then every 24 hours; weighing prior to dosing and 24 hours, 7 and 14 days after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical symptoms were noted.
- Gross pathology:
- - Males: swelling of stomach mucosa
- Females: swelling of stomach mucosa and partial inflammation of the intestine
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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