Sodium toluene-4-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-06 to 1989-09-21

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:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium toluene-4-sulphonate

EC Number:

211-522-5

EC Name:

Sodium toluene-4-sulphonate

Cas Number:

657-84-1

Molecular formula:

C7H7O3S.Na

IUPAC Name:

4-methylbenzenesulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Winkelmann, Borchen, Germany- Age at study initiation: not mentioned- Weight at study initiation: 222 g (mean weight)- Fasting period before study: 16 hours- Housing: 1 - 5 animals in Makrolon cages, type III- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany- Water (e.g. ad libitum): Drinking water ad libitum- Acclimation period: 5 - 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 1- Humidity (%): 60 ± 5- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kgVEHICLE- Concentration in vehicle: 30 %- Amount of vehicle (if gavage): 10 cm³/kgMAXIMUM DOSE VOLUME APPLIED: 10 cm³/kgDOSAGE PREPARATION (if unusual): The test substance was dissolved in deionised water by means of slight heating.

Doses:

3000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.- Necropsy of survivors performed: yes- Other examinations performed: no

Statistics:

The means of the body weights were calculated. The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 850

Based on:

act. ingr.

Remarks on result:

other: -

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: -

Mortality:

male: 0/5female 0/5

Clinical signs:

other: All animals showed the following clinical symptoms 2 hours post applicationem: diarrhea, slight piloerection, squatting position. Later on retarded movements, intense piloerection, brownish nares and soiling of the anal region were noted. 9 of 10 animals

Gross pathology:

Dissection of surviving animals at the end of the experiment showed no macroscopically visible organ changes.

Any other information on results incl. tables

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
3000	0/5	0/5	0/10	-	5/5	5/5	10/10

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 to male and female rats was greater than 3000 mg/kg bw correspondign to > 2850 mg/kg bw based on active ingredient.

Executive summary:

The acute Oral Toxicity of Sodium toluene 4-sulphonate was assessed following official method OECD 423, Acute Toxic Class Method. The limit test was performed with a single dose of 3000 mg/kg bw based on test material administered to both males and females Wistar rats.

All animals showed the following clinical symptoms after 2 hours post application: diarrhea, slight piloerection, squatting position. Later on retarded movements, intense piloerection,  brownish nares and soiling of the anal region were note on 9 of 10 animals.

Dissection of surviving animals at the end of the experiment showed no macroscopically visible organ changes.