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Toxicological information

Acute Toxicity: other routes

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Administrative data

acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guidelines, nor under a quality assurance system. The study focuses on determining if the substance is hazardous to the renal function.

Data source

Reference Type:
Trichloroaniline effects on renal function in vivo and in vitro
Lo HH, Brown PI, Rankin GO
Bibliographic source:
Toxicology Letters, 1991, vol. 57, p. 319 - 328

Materials and methods

Test guideline
no guideline followed
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
not specified
Details on test material:
No data.

Test animals

Fischer 344
Details on test animals or test system and environmental conditions:
- Source: Hilltop Lab Animals, Inc. (Scottdale, PA)
- Weight at study initiation: 220-275 g
- Housing: stainless-steel metabolism cages
- Diet (e.g. ad libitum): animals were pair-fed.
- Acclimation period: 1 week, maintained in standard plastic cages until use.

Administration / exposure

Route of administration:
other: seasame oil
Treated rats received the test compound at the dose 0.8 or 1.5 mmol/kg. Control rats received sesame oil (2.5 ml/kg) only.
No. of animals per sex per dose:
4 rats/group
Control animals:
Details on study design:
- Duration of observation period following administration: 48 h
- Frequency of observations and weighing: Food and water intake and body weight also were measured daily. Urine volume was measured at 24 and 48 h. Urine contents were semiquantitatively analyzed at 6 and 30 hours for the presence of protein, glucose and blood using Multistix’K’ (Ames Division, Miles Laboratories, Inc.).
- Necropsy of survivors performed: yes. The rats were killed by cervical dislocation. The left kidney was removed, renal cortical slices prepared freehand, and the accumulation of 14C-labelled para-aminohippurate (PAH) and tetraethylammonium (TEA) by these slices determined. The right kidney also was rapidly removed, weighed, cut into quarters and fixed in 10% neutral-buffered formalin solution for histological examination using light microscopy.
The data were analyzed using one-way analysis of variance and/or Student’s t-tests.

Results and discussion

Other findings:
Observation of the renal function:
Low-dose 0.8 mmol/kg treatment did not alter urine volume at 24 h, but reduced urine volume at 48 h whereas high-dose 1.5 mmol/kg treatment induced mixed responses - at 24 h a significant increase of urine volume was observed which came bacl to normal at 48 h post-treatment. Urine contents were not altered by high- or low-dose treatment.
TEA (tetraethylammonium) uptake was decreased in the 1.5 mmol/kg treatment groups. No significant changes in renal morphology at 48 h with the doses tested.

Any other information on results incl. tables

Table 1: Effect of TCA administration on BUN concentration and kidney weight at 48 h.

Dose (mmol/kg) Group BUN concentration (mg%) Kidney weight (g/100 g bw)
0 h 48 h
0.8 Control 24± 1 23 ± 1 0.37 ± 0.01
Treated 23 ± 4 25 ± 1 0.36 ± 0.01
1.5 Control 25 ± 1 23 ± 1 0.37 ± 0.01
Treated 23 ± 2 24 ± 2 0.38 ± 0.01

To ascertain if renal toxicity had occurred earlier than 48 h, a second set of experiments was conducted. Groups of rats were treated as described earlier, but only the 1.5 mmol/kg dose. However, no changes in renal function or morphology were noted.

Applicant's summary and conclusion

Under the testing conditions the test item was reported as not being a nephrotoxicant.
Executive summary:

The study was conducted in order to measure the effect of the test item on the renal function, based on a single dose administration. Two different groups of animals for dose 0.8 and 1.5 mmol/kg were sacrified after 48 h and the kidneys were removed for analysis. Only minor renal effects were observed.