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EC number: 433-260-2 | CAS number: 168253-59-6
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 guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 433-260-2
- EC Name:
- -
- Cas Number:
- 168253-59-6
- Molecular formula:
- C22H40N2O8
- IUPAC Name:
- 1,5-bis[1,2-bis(ethoxycarbonyl)ethylamino]-2-methylpentane
- Details on test material:
- - Stability in vehicle: verified in an analytical test conducted under GLP
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Strain: Hsd Cpb:WU
- Age at study initiation: 8-10 weeks old
- Weight at study initiation: mean weight 216 g (for males) and 187 g (for females)
- Fasting period before study: 16-17 h
- Housing: in goups of 3 animals
- Diet and Water: ad libitum
- Acclimation period: at least 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Application volume: 10 ml/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: several times on the day of administration, and at least once daily during the observation period.
- Frequency of weighing: directly before administration, after one week (only females) and at the end of the observation period or after death.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed after the application or during the 15-days post-application period.
- Clinical signs:
- other: No signs of intoxication occured during the observation time at all animals.
- Gross pathology:
- The animals sacrificed at the end of study showed no noticeable gross pathological findings.
- Other findings:
- None
Applicant's summary and conclusion
- Executive summary:
An oral toxicity study (OECD TG 423) with a starting dose of 2000 mg/kg bw was performed with 3 male and 3 female rats. No mortality, no clinical signs and no gross pathological findings were observed after application of the test substance in the 15-days observation period. Therefore, the LD50 was estimated to be > 2000 mg/kg bw.
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