Registration Dossier
Registration Dossier
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EC number: 928-729-8 | CAS number: 188416-20-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 21 November 1997 to 18 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- EC Number:
- 928-729-8
- Cas Number:
- 188416-20-8
- Molecular formula:
- C16H13ClF3N5O.HCl
- IUPAC Name:
- 3-(6-chloro-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol hydrochloride
- Details on test material:
- - Analytical purity: 90%
- Lot/batch No.: 5ABJ002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Harlan U.K.Ltd., Bicester, Oxon, England
- Age at study initiation: approximately five to seven weeks of age
- Weight at study initiation: 80 to 103g
- Fasting period before study: overnight prior to dose
- Housing: Sub-Dividable Rodent Cage-Polished stainless steel 20cmhigh*39cmwide*39cmlong, no more than five animals of the same sex were accommodated in each cage.
- Diet : a standard laboratory rodent diet
- Water : ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21ºC
- Humidity (%): 46-72%
- Air changes (per hr):
- Photoperiod : 12 hours of artificial light (0700-1900hours) in 24-hour period
IN-LIFE DATES: From: 13 May 1998To: 18 May 1998
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1% w/v
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a preliminary study was conducted to help define the toxic potential of the test substance and aid in selection of a suitable dosage for the main study. - Doses:
- Dose volume (ml/kg): 10ml/kg
Dose (mg/kg) Prelim study: 500 - 2000mg/kg
Main study: 2000mg/kg - No. of animals per sex per dose:
- Prelim study: 1 female (500 mg/kg) , 1 female (2000 mg/kg)
Main study:5 males, 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice daily. The body weight in the preliminary study was recorded on Day 1( prior to dosing) and 8 and in the main study on Days 1( prior to dosing), 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
- Preliminary study:
- Treatment groups each comprising one female rat were treated at 500 and 2000mg/kg bodyweight.
The results from the preliminary study indicated the actue lethal oral dose of this substance to rats was greater than 2000mg/kg bodyweight.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: Piloerection was observed in all rats within seven minutes of dosing . This sign persisted and was accompanied on Day 1 or thereafter during the study by: hunched posture, waddling/ unsteady gait and pallid extremities, notable in all rats and accompanied
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute lethal dermal dose to rats of this substance was demonstrated to be greater than 2000mg/kg bodyweight.
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