Registration Dossier
Registration Dossier
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EC number: 941-267-1 | CAS number: 1445870-18-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented, according to OECD guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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 (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate
- EC Number:
- 941-267-1
- Cas Number:
- 1445870-18-7
- Molecular formula:
- C29H55NO4
- IUPAC Name:
- 2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 10 weeks
- Fasting period before study: 16h before administration
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration and at least once during each workday thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred in both administration groups.
- Clinical signs:
- other: No clinical signs were observed in both administration groups during clinical examination.
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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