Registration Dossier
Registration Dossier
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EC number: 266-549-5 | CAS number: 67024-46-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 to 18 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Isopropyl 2-ethylhexanoate
- EC Number:
- 266-549-5
- EC Name:
- Isopropyl 2-ethylhexanoate
- Cas Number:
- 67024-46-8
- Molecular formula:
- C11H22O2
- IUPAC Name:
- isopropyl 2-ethylhexanoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female, nulliparous and non pregnant animals.
Age of animals: Young adult rat, 8-9 weeks old in sighting and in main study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
- Doses:
- A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
- No. of animals per sex per dose:
- A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
- Control animals:
- no
- Details on study design:
- A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No.
- Clinical signs:
- No treatment related symptoms were observed in the 2000 mg/kg bw dose group throughout the 14-day post-treatment period.
- Body weight:
- The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.
- Gross pathology:
- Slight hydrometra was observed in three females (No.: 7534, 7560, 7557). Hydrometra is physiological finding and connected to the oestrus cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- LD50 >2000 mg/kg.
- Conclusions:
- No lethality was noted at after a single oral dose of 2000 mg/kg bw.
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