Registration Dossier
Registration Dossier
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EC number: 929-947-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-02-05 to 2008-03-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- [(3R)-3-[2-hydroxy-5-(hydroxymethyl)phenyl]-3-phenylpropyl]bis(propan-2-yl)azanium (2R)-2-(acetyloxy)-2-phenylacetate
- EC Number:
- 929-947-6
- Molecular formula:
- C22H31NO2 • C19H10O4
- IUPAC Name:
- [(3R)-3-[2-hydroxy-5-(hydroxymethyl)phenyl]-3-phenylpropyl]bis(propan-2-yl)azanium (2R)-2-(acetyloxy)-2-phenylacetate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor and E010005910
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: +-20% of 226g
- Fasting period before study: 4 hours
- Housing: uspended solid-floor polypropylene cages furnished with woodflake
- Diet (e.g. ad libitum): Certified rat and mouse diet ad libitum, except for a fasting period of 4 hours prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 300 mg active ingriedient/kg bodyweight, 50 mg active ingredient/kg bodyweight
- Amount of vehicle (if gavage): 10 ml active ingredient/kg bodyweight
- Justification for choice of vehicle: The test material did not dissolve/suspend in distilled water
MAXIMUM DOSE VOLUME APPLIED: 10 ml active ingredient/kg bodyweight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was an absence of data regarding the toxicity of the test material. - Doses:
- 300 mg active ingriedient/kg bodyweight and 50 mg active ingredient/kg bodyweight
- No. of animals per sex per dose:
- 1 for 300 mg active ingriedient/kg bodyweight
6 for 50 mg active ingredient/kg bodyweight
All were females. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical signs and body weight examinations were performed.
Results and discussion
- Preliminary study:
- One mouse given a dosage level of 300 mg active ingredient/kg bodyweight. Hunched posture was noted at 4 hours, and at 1 day signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, dehydration, decreased respiratory rate and pallor of the extremities. The animal was killed in extremis one day after dosing. Patchy pallor of the liver was noted at necropsy. Based on this information, a dose level of 79 mg/kg bodyweight was selected for investigation.
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 79 - <= 471 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - <= 300 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Based on this information, a dose level of 79 mg/kg® bodyweight was selected for investigation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The test substance was classified as a category 3 for acute oral toxicity according to GHS criteria.
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