Pyridinium toluene-4-sulphonate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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).

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

Conclusions:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the acute oral toxicity study no death occurred after a single dose of 4000 mg/kg body weight. Accordingly, classification for acute oral toxicity is not needed.

Non-classification for acute dermal and inhalation toxicity is justified because of the low acute systemic toxicity observed in the oral study.