Registration Dossier
Registration Dossier
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EC number: 700-402-2 | CAS number: 860035-10-5
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
Test material
- Reference substance name:
- 1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate
- EC Number:
- 700-402-2
- Cas Number:
- 860035-10-5
- Molecular formula:
- C11H15NO7
- IUPAC Name:
- 1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Doses:
- 300mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of the test material in female Sprague-Dawley rats was estimated to be in the range 300-2000mg/kg bw.
- Executive summary:
Following a sighting test at dose levels of 300mg/kg and 2000mg/kg, a further group of four fasted female Sprague-Dawley CD strain rats were given a single oral dose of the test material, as a solution in DMSO ata dose level of 300mg/kg. Clinical signs and bodyweight development were moitored during the study.and all animals were subject to gross necrospy. The animal treated at 2000mg/kg was killed in extremis four hours after dosing and abnormalities at necropsy included haemorrhage and epithelial sloughing of the gastric mucosa. Signs of systemic toxicity noted during the observation period were hunched posture, lethargy, ataxia, gasping, laboured and noisy respiration. Two animals treated at 300mg/kg appreared normal throughout the observation period and the remaining animals in this group appeared normal one day after dosing. There were no deaths at 300mg/kg and the estimated oral LD50 was estimated to be between 300 -2000mg/kg.
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