Registration Dossier
Registration Dossier
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EC number: 228-528-9 | CAS number: 6289-46-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-06 to 2003-05-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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:
- Dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
- EC Number:
- 228-528-9
- EC Name:
- Dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
- Cas Number:
- 6289-46-9
- Molecular formula:
- C10H12O6
- IUPAC Name:
- 1,4-dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): DIMETHYLSUCCINYLOSUCCINATE
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- • Step 1: 300 mg per kg body weight.
• Step 2: 300 mg per kg body weight.
• Step 3: 2000 mg per kg body weight.
• Step 4: 2000 mg per kg body weight. - No. of animals per sex per dose:
- groups of 3 females each per dosing step
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: Only the high dosed animals were affected. Piloerection and hunched posture, which are attributed to discomfort.
- Gross pathology:
- All animals were normal at the necropsy 14 d p.a.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50, oral: > 2000 mg/kg body weight
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance after a single peroral administration to rats.
Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001.
"DIMETHYLSUCCINYLOSUCCINATE" was administered once by stomach intubation to female Crl:CD(SD)IGS BR rats as a suspension in 0.1 % aqueous carboxymethyl cellulose. The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose. The dose volume was 10 mL per kg body weight for all groups.
Investigations were performed as follow:
• Body weights: before administration, 7 and 14 days after the administration (p.a.).
• Clinical observations: at least once per day.
• Necropsy: The animals were sacrificed and necropsied 14 days p.a.
Findings were als follows:
• All animals survived until the scheduled termination of the study.
• Only the high dosed animals were affected. Piloerection and hunched posture, which are attributed to discomfort.
• All animals gained weight in both weeks p.a
• All animals were normal at the necropsy 14 d p.a.
• LD50, oral: > 2000 mg/kg body weight
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