Toluene-4-sulphonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A 2 page study report is available. The study was performed pre-GLP. The study was performed according to a method similar to OECD401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Very high dose volume. Animals were only observed for signs of intoxication and necropsy was performed on surviving animals.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Toluene-4-sulphonamide

EC Number:

200-741-1

EC Name:

Toluene-4-sulphonamide

Cas Number:

70-55-3

Molecular formula:

C7H9NO2S

IUPAC Name:

4-methylbenzene-1-sulfonamide

Constituent 2

Reference substance name:

p-Toluenesulfonamide

IUPAC Name:

p-Toluenesulfonamide

Test material form:

solid: crystalline

Details on test material:

Name: para-toluene sulphonamide
Appearance: white-coloured crystalline powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: TNO
Body weight: males 242 to 380 g, females 120 to 180 g.
The rats were housed in groups of five in screem-bottomed stainless steel cages, in a well-ventilated room, maintained at 23-250 C.
Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

2075, 2500, 3000, 3600, 4325 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Dosing: By gavage as 25 % (w/v) suspension in propylene glycol to groups of five males and five females in single doses of 8.3, 10.0, 12.0, 14.4 or 17.3 ml per kg body weight.
They were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors.

Statistics:

The LDso was calculated according to the method of Wei! (Biometrics 8, (1952) 249-263).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 330 mg/kg bw

95% CL:

2 080 - 2 600

Any other information on results incl. tables

Results:

Within a few hours after dosing the rats showed sluggishness, followed by loss of consciousness. Death occurred between 4 and 50 hours after dosing. Later on the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors at autopsy revealed dark discolouration of the liver in the rats of all dose groups. Some of the rats showed mottled kidneys. No other signs of treatment-related gross alterations were seen.

Dose		Mortality
Suspension ml/kg	Test substance g/kg	males	females	%
8.3	2.08	1/5	3/5	40
10.0	2.50	1/5	4/5	50
12.0	3.00	4/5	5/5	90
14.4	3.60	3/5	5/5	80
17.3	4.33	5/5	5/5	100

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

From the mortality-figures the LD50 of para-toluene sulphonamide was calculated to be 2.33 g per kg body weight, with 2.08 and 2.60 as the 95% confidence limits. Therefore, the test substance can be classified in Category V according to GHS.

Executive summary:

An acute oral toxicity study was performed according to a method similar to OECD401 and pre-GLP. 5 male and 5 female rats were dosed with 8.3, 10.0, 1.20, 14.4 or 17.3 ml/kg bw. The animals were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors. Within a few hours after dosing the rats showed sluggishness, followed by loss of consciousness. Death occurred between 4 and 50 hours after dosing. Later on the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors at autopsy revealed dark discolouration of the liver in the rats of all dose groups. Some of the rats showed mottled kidneys. No other signs of treatment-related gross alterations were seen. From the mortality-figures the LD50 of para-toluene sulphonamide was calculated to be 2.33 g per kg body weight, with 2.08 and 2.60 as the 95% confidence limits. Therefore, the test substance can be classified in Category V according to GHS.