Registration Dossier
Registration Dossier
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EC number: 272-964-2 | CAS number: 68921-83-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 7, 1978 to November 21, 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- According to Hagan, E.C. (1959) Acute Toxicity; Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, pp. 17 - 25.
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride
- EC Number:
- 272-964-2
- EC Name:
- Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride
- Cas Number:
- 68921-83-5
- Molecular formula:
- C39H79N2O3.Cl
- IUPAC Name:
- dimethyl(3-octadecanamidopropyl)[2-oxo-2-(tetradecyloxy)ethyl]azanium chloride
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
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: Summit View Farm, Belvidere, New Jersey
- Diet: ad libitum (Wayne animal feeds):
- Water: ad libitum):
- Housing: maintained under standard laboratory conditions for a minimum of seven days, and fasted overnight prior to adminstration of the test material.
- Weight at study initiation: 214-240 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- The rats were dosed individually by gavage, according to bodyweight
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage.
Observations were made daily thereafter to a total of fourteen days.
Animals sacrificed at the end of the 14-day observation period were subjected to complete gross necropsy.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Mortality:
- 1 male died on day 9 following exposure.
- Clinical signs:
- other: Slight Depression in two male rats after 24 h following dosing.
- Gross pathology:
- No gross changes observed in the surviving rats, fibrous tissue encasing heart and lungs in the rat that died.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CERAPHYL® 70 is not a toxic material orally to rats under conditions of this test.
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