Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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.