Pyridinium toluene-4-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): BYK-CATALYST 450 WS 30,6%-ig in Wasser
- Substance type: UVCB
- Physical state: clear, slight viscous fluid
- Lot/batch No.: HH-041-00

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- SPF-Wistarrats strain Winkelmann, Paderborn
- Mean weight males: 210 - 230 g
- Mean weight females: 200 - 215 g
- Fasting period before study: 16 hours
- Housing: 3 animals per sex per cage, randomly divided in single cages
- Diet: laboratory standard diet (Altromin, Lage), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 ± 2.5 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The fluid (test substance) was warmed at 40 °C and suspended in water.
Administration by oral gavage, using a non-flexible stomach tube.

Doses:

Group 1: 2000 mg/kg/bw (10 p.c.)
Group 2: 4000 mg/kg/bw (20 p.c.)
Frequency: single dosage, on day 1

No. of animals per sex per dose:

3 animals per dose/sex

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic organ changes

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured.

Clinical signs:

No clinical signs of systemic toxicity were noted.

Body weight:

There was no test dependent deviation on development in weight gains after 14 days observation time. This was compared within both test groups and against controls in standard keeping.

Gross pathology:

No clear pathologic findings did occur in final autopsy in any of big body cavities and no pathological changes macroscopically could be observed which were due to the test procedure or the test compound.

Other findings:

None

Applicant's summary and conclusion

Conclusions:

The oral LD50 value in Wistar rats was established to exceed 4000 mg/kg body weight.