Registration Dossier
Registration Dossier
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EC number: 700-792-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 May - 25 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Experimental study conducted in GLP compliant lab according to EC and OECD test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
- EC Number:
- 700-792-4
- Molecular formula:
- C26H51NO2, C28H55NO2
- IUPAC Name:
- Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate
- Test material form:
- other: white to pale yellow solid
- Details on test material:
- - Name of test material (as cited in study report): T-1640L
- Physical state: white to pale yellow solid
- Analytical purity: 98.74%
- Purity test date: 20 May 2011
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 12 April 2013
- Stability under test conditions: stable
- Storage condition of test material: refrigerated in the dark under dry conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited industrial supplier
- Age at study initiation: ca. 8 - 12 weeks
- Weight at study initiation: 185 to 233g
- Fasting period before study:
- Housing: solid bottomed polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): ad libitum, Rat and Mouse No. 1 Maintenance Diet
- Water (e.g. ad libitum): potable water from public water supply available ad libitum
- Acclimation period: at least 5 days prior to start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23C
- Humidity (%):40 - 70%
- Air changes (per hr):The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
IN-LIFE DATES: From: To: 1 May - 25 May 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1% w/v
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Selected following formulation trials
- Lot/batch no. (if required): Test formulation prepared on day of dosing
- Purity:N/a
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): N/a
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Acute toxic class method, starting dose selected in compliance with study guidelines (300 mg/kg) - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 3 female rats per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily observations but more frequently on day of dosing, rats weighed on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- No clinical signs
- Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- Macroscopic examination at study termination on Day 15 revealed a small (atrophy) stomach in two females dosed at 300 mg/kg. No abnormalities
were revealed in any other animal at the macroscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of T-1640L was demonstrated to be greater than 2000 mg/kg bodyweight.
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