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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1985

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

Constituent 1
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

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.