Registration Dossier
Registration Dossier
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EC number: 686-853-5 | CAS number: 46921-17-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- november to december 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Other name of 4,4-Dimethyl-2-undecyl-2-oxazoline : cycloceramide
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Nulliparous and non-pregnant females
Age : 7 weeks at the begining of the study
Maximum of 3 animals per cage
The artificial lighting ensured a sequence of 12h light and 12 h dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Admistration in a single dose with a syringe
- Doses:
- Step 1 and 2 : 2000 mg/kg of body weight of test element
- No. of animals per sex per dose:
- Step 1 : 3 animals
Step 2 : 3 animals - Control animals:
- not specified
- Details on study design:
- Stepwise procedure
Animals daily observed for at least 14 days after administration. The day of admistration, animals wer regularly observed (immediately, during 30 min following gavage, 1h, 2h, 3h and 4h)
Parameters observed : spontaneous activity, Preyer's reflex, respiratory effect, convulsions, tremors, temperature, muscular tone, grip strengh, palpebral ptosis, mydriasis, salivation, lacrimation, turnaround, reflex, piloerection, diarrhoea, lethargy, coma, changes inskin, fur eyes, mucous membranes and death
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Clinical signs:
- other: A slight piloerection was observed just after treatment, then no symptom at all was observed anymore.
- Gross pathology:
- None
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Not classified
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