Registration Dossier
Registration Dossier
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EC number: 941-981-3 | CAS number: -
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:
- 1 995
- Report date:
- 1995
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, C18 unsaturated, ethyl & methyl esters
- EC Number:
- 941-981-3
- Molecular formula:
- not available, substance is UVCB
- IUPAC Name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab animals, Scottdale, Pennsylvania, USA
- Weight at study initiation: 203 - 213 g (males), 189 - 209 g (females)
- Fasting period before study: approximately 21 h
- Housing: individually housed in suspended stainless steel caging with mesh floors
- Diet: Purina Rodent Chow #5012, ad libitum
- Water: filtered tap water, ad lbitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- 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: Individual weights were recorded just prior to test substance administration and again on days 7 and 14 (termination), the animals were observed for signs of gross toxicity, behavioral changes and mortality at 1, 3 and 24 h post-dosing and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: yes (tissues of the thoracic and abdominal cavities were examined)
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 during the study period.
- Clinical signs:
- No clinical signs occurred during the study period.
- Body weight:
- All animals gained weight.
- Gross pathology:
- Gross necropsy findings were generally unremarkable.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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