Registration Dossier
Registration Dossier
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EC number: 601-507-5 | CAS number: 118135-28-7
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 study according EU/OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane
- EC Number:
- 601-507-5
- Cas Number:
- 118135-28-7
- Molecular formula:
- C13H23ClO2
- IUPAC Name:
- 8-tert-butyl-2-(chloromethyl)-1,4-dioxaspiro[4.5]decane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: demineralized water with Cremophor EL 2% (V/V).
- Doses:
- male: 10, 100, 500, 1000, 3000, 4000, 4500, 5000 mg/kg bw
female: 500, 1000, 3000, 3150, 3500, 4000, 5000 mg/kg bw - No. of animals per sex per dose:
- 5 animal per sex and dose
- Control animals:
- no
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 574 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 378 mg/kg bw
Any other information on results incl. tables
For the male rats, an approximate LD50 of 4378 mg/kg b.w. was determined, and for the females an LD50 of 3574 (3169 - 4033) mg/kg b.w. The main signs of intoxication were generally conspicuous and were as follows: apathy, rough coats, reduced motility, tachypnea and labored breathing, staggering and/or spastic gait, salivation (occasionally red), narrowed palpebral slits, periodic twitching, loss of weight, emaciation, spasms, prostration, pallor, digging behavior, splayed rear legs, red nasal discharge, red-encrusted snouts, increased urine discharge, increase water intake, damp anus, light-colored and soft feces, vocalization on touching (F), red-encrusted front paws (F) and yellow-colored bedding at urination sites. These signs occurred shortly after administration and lasted among the males until max. day 11 and among the females until max. day 18 of the study. A dose of 10 mg/kg b.w. was tolerated by the males and a dose of 500 mg/kg b.w. by the females without signs occurring.
Applicant's summary and conclusion
- Conclusions:
- The test article was of low toxicity following acute oral administration to male and female rats.
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