Registration Dossier
Registration Dossier
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EC number: 226-518-9 | CAS number: 5417-35-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.10.2000 - 26.02.2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD and GLP guidelines, old OECD guidance used, one inconsistency in the report
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4,7-dihydro-2-isopropyl-1,3-dioxepin
- EC Number:
- 226-518-9
- EC Name:
- 4,7-dihydro-2-isopropyl-1,3-dioxepin
- Cas Number:
- 5417-35-6
- Molecular formula:
- C8H14O2
- IUPAC Name:
- 2-(propan-2-yl)-4,7-dihydro-2H-1,3-dioxepine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Doses:
- 2000 / 930 / 430 / 200 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 000.31 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 166.28 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance has to be classified as acut tox class 4 oral, H302
- Executive summary:
Acute toxicological symptoms attributed to the exposure to Isopropyldioxepen could be observed in
10 rats dosed with 2000 mg/kg, in 3 rats dosed with 930 mg/kg, in 0 rats dosed with 430 mg/kg and
in 0 rats dosed with 200 mg/kg. The post-mortem findings did not show any macroscopic organ
changes. The LD50 value of Isopropyldioxepen was determined to 1000.31 mg/kg for male rats and
to 1166.28 mg/kg for female rats according to Moving Average Computation.
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