Registration Dossier
Registration Dossier
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EC number: 617-441-5 | CAS number: 83121-18-0
Specific investigations: other studies
Administrative data
- Endpoint:
- hematoxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2019
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- The effect of Teflubenzuron and Bacillus thuringiensis on some haematolgical parameters of albino rats.
- Author:
- Naglaa F. Reyad and Rahma N. Jrais
- Year:
- 2 019
- Bibliographic source:
- Life Science Journal 2019;16(3):60-63
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A study was conducted evaluate the toxicological and hematological effects of the substance on male albino rats. The substance was administered for 3 months via oral gavage every other day using 105 mg/kg bw/day.
- GLP compliance:
- not specified
- Type of method:
- in vivo
- Endpoint addressed:
- repeated dose toxicity: oral
Test material
- Reference substance name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 617-441-5
- Cas Number:
- 83121-18-0
- Molecular formula:
- C14 H6 Cl2 F4 N2 O2
- IUPAC Name:
- 1-(3,5-dichloro-2,4-difluorophenyl)-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Farm of Central Organization of Serum & Vaccine (Abasia Farm, Egypt)
- Age at study initiation: no data
- Weight at study initiation: 120-150 g
- Housing: housed in plastic cage under hygienic condition
- Diet: ad libitum, commercial pellet diet and barley (natural ingredient diet); The diet includes protein, minerals, vitamins, energy resources and other beneficial dietary constituent as recommended by (National Research Council (NRC). 1995) and the diet of the rats of the present study was supported with Soya Bean
- Water: ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test item was freshly prepared prior to every treatment. It was dissolved in saline solution.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- every other day
- Post exposure period:
- no
Doses / concentrations
- Dose / conc.:
- 105 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Examinations:
- Blood samples were obtained from the retroorbital plexus and the tail using 21-gauge needle of overnight fasted rats. Blood was collected into heparinized tube for assay of the complete blood picture.
- Positive control:
- no
Results and discussion
- Details on results:
- Clinical signs: Rats treated with the test item at 1/10 of its LC50, developed clinical symptoms, which were progressing by time marked distension of the abdomen. This was the only clinical symptom observed in rats after the first two weeks of treatment. In the third week, rats lost their vitality and activity. Some rats developed nervous manifestation and moved in circles. During the remaining weeks of the experiments, general weakness and cachexia were observed. The animals were reluctant to move and showed nervous manifestation and hurried respiration.
Body weight and organ weights: The substance caused a significant decrease in body weight of rats, increased liver weight but the kidney weight was decreased. In addition there was a slightly decrease in testicular weight as compared to the level in the control group.
Hematology: decreased Hb% (14.31 g/dl in the 1st week to 7.29 in the 3rd week), RBC count (5.11x10E6 celllmm in the 1st week to 2.8 x10E6 celllmm in the 3rd ), Hematocrite% (Hct%) (43% in the 1st week to 21% in the 3rd week ), mean corpuscular volume (MCV) (87Fl in the 1st week to 78Fl in the 3rd week), mean corpuscular haemoglobin concentration (MCH) (28.03 pg in the 1st week to 26.3 pg in the 3rd week ) and platelets (430.36 x10E3 cell/min in the 1st week to 280.66 x10E3 cell/min in the 3rd week) except the leucocytes (WBCs) that showed significant increase
Applicant's summary and conclusion
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