Registration Dossier
Registration Dossier
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EC number: 237-159-2 | CAS number: 13674-87-8
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented and scientifically acceptable study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
- Principles of method if other than guideline:
- Tubular necrosis was determined according to Calder et al (1979) and Soderlund et al (1980).
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Tris-CP
- Obtained from Chem.Service, West Chester, PA
- Analytical purity not stated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding Centre, Ejby, Denmark
- Weight at study initiation: 180-250 g
- Diet (e.g. ad libitum): standard pellet diet (Ewos R 3, Astra Ewos, Sodertalje, Sweden) at libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- DMSO
- Details on exposure:
- Wistar rats, 10 per group, received a single intraperitoneal dose of 500 mg of the test substance per kg bodyweight in DMSO (<0.25 ml/100 g bodyweight). The control group received vehicle alone.
- Doses:
- 0 and 500mg/kg bw.
- No. of animals per sex per dose:
- 10 animals per dose group.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 48 hours
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: kidneys only
- Other observations: plasma urea, creatinine and glutamic oxalacetic transaminase were determined using convetional reagent kits. - Statistics:
- All statistical comparisons were carried out using Student's t-test.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- > 500 mg/kg bw
- Mortality:
- one rat in the Tris-CP treatment group died.
- Body weight:
- - Kidney/body weight ratios were significantly increased over the controls
- Gross pathology:
- - TDCP did not cause any signs of nephrotoxicity (no histopathological changes)
- No histopathologcal changes indicative of cell necrosis were found in the kidneys.
- No histological evidence of liver necrosis - Other findings:
- - No changes in plasma urea and creatinine were observed.
Applicant's summary and conclusion
- Conclusions:
- 500mg Tris-CP injected intraperitoneally in Wistar rats does not cause significant histopathological changes in kidney, but does show increased kidney / body weight ratios.
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