Registration Dossier
Registration Dossier
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EC number: 814-375-0 | CAS number: 67036-09-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.04.2018 to 24.07.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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
- Limit test:
- yes
Test material
- Reference substance name:
- [2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
- EC Number:
- 814-375-0
- Cas Number:
- 67036-09-3
- Molecular formula:
- C12H26N2OCl
- IUPAC Name:
- [2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- WISTAR Crl: WI(Han) rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Step 1: 139–146 g; Step 2: 146–167 g
- Housing: Full barrier in an air-conditioned room
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral
gavage administration at a dosage of 2000 mg/kg body weight. The test item was dissolved with the
vehicle aqua (sterile water) at a concentration of 0.2 g/mL and administered at a dose
volume of 10 mL/kg.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- aqua (sterile water)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10ml/kg bw
- Justification for choice of vehicle: non-toxic characteristics.
- Lot/batch no. (if required): 705820 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 per step / 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for 14 days after dosing
- Frequency of weighing: on day 1 (prior to the administration) and on days 8 and 15 where day 1 is defined as the day of administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, morbidity and mortality, body weight, gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: minor signs of toxicity with slight piloerection within 4 hours after application. One animal continued to show slight piloerection on the day after application and recovered within 2 days post-dose.
- Gross pathology:
- no findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item TMA-TEMPO to
rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.
The median lethal dose of TMA-TEMPO after a single oral administration to female rats, observed
over a period of 14 days is:
LD50 cut-off (rat): >5000 mg/ kg bw
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