Tris[2-chloro-1-(chloromethyl)ethyl] phosphate

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:

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

Test material information

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.