Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

The Acute Intravenous Toxicity of Biological Stains, Dyes, and Other Fluorescent Substances

Author:

Lutty GA

Year:

1978

Bibliographic source:

TOXICOLOGY AND APPLIED PHARMACOLOGY 44, 225 - 249

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test: intravenous injection in the caudal vein to establish a LD50
- Short description of test conditions:
An intravenous LD50 was determined for several dyes with sufficient solubility and promise with regard to lethal dose. All dyes were administered in distilled water at their maximum solubility. The injections were given in the caudal vein of male Swiss-Webster mice, 25-30 g. Dose ranging was done with two mice per dose. Three doses were used for determination of the LD50, 10 mice per dose. The results were plotted on probit number of deaths vs log dose scales (Hagan, 1959). The mice were held for 14 days and then sacrificed by cervical dislocation.
- Parameters analysed / observed:
The thoracic and abdominal cavities of the mice, at least in the highest dosage group, were examined for macroscopic pathological changes.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

EC Number:

228-783-6

EC Name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Cas Number:

6358-69-6

Molecular formula:

C16H10O10S3.3Na

IUPAC Name:

trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Test animals

Species:

mouse

Strain:

Swiss Webster

Sex:

male

Administration / exposure

Route of administration:

intravenous

Vehicle:

water

Details on exposure:

single application

Doses:

3 doses up to maximum solubility

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
The thoracic and abdominal cavities of the mice, at least in the highest dosage group, were examined for macroscopic pathological changes.

Histopathological examination: Seven male Swiss-Webster mice were given 370 mg/kg bw (0.1 ml) of dye in distilled water via the caudal vein.

Two mice were sacrificed 2 days after injection, and the remaining five, at 14 days after injection.
Body weights were recorded on the day of injection and on the day of sacrifice. During the 14 days, the mice were observed for excretion of dye, unusual behavior, and general physical appearance.
Biopsies were performed on mice anesthetized with ether on Days 2 and 14. The inguinal, caudal, and lumbar lymph nodes were removed first, then the spleen, kidneys, and liver.
All tissues were preserved in 10% neutral-buffered formalin. The organs were weighed, formalin-wet, before trimming for paraffin processing. All sections were stained with Ehrlich’s hematoxylin and eosin (H and E). After viewing the H and E sections, McManus’ Pas and Gomori’s reticular stains were done if elaboration of lesions was necessary.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 050 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Results were only given in short tabular form:

LD50 1050 mg/kg bw

Excretion iv: 89% in urine

Growth: normal

Organ weight: normal

Injection reaction: none

Histopathological chages: reactive hyperplasia du to fighting lacerations

Observations and conclusions: Nontoxic