4'-anilinotoluene-4-sulphonanilide

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:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-anilinotoluene-4-sulphonanilide

EC Number:

202-902-1

EC Name:

4'-anilinotoluene-4-sulphonanilide

Cas Number:

100-93-6

Molecular formula:

C19H18N2O2S

IUPAC Name:

4'-anilinotoluene-4-sulphonanilide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

olive oil

Doses:

The required amount of the test item (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration.
The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours.

Control animals:

yes

Remarks:

8-12 weeks; female animals were non-pregnant and nulliparous

Statistics:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose level.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.

Clinical signs:

No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reactions.

Body weight:

The body weight of all animals increased during the study. Summary results of body weights are presented in Table 3.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Any other information on results incl. tables

Body Weight

Sex	Dose	ID	Body Weight (g)			Body Weight Difference (g)
			Initial	Week 1	Week 2	Week 1-Initial	Week 2-Initial	Week 2-Week 1
♀	2000 mg/kg	1	180	210	220	30	40	10
		2	185	210	220	25	35	10
		3	175	205	215	30	40	10
		4	180	205	210	25	30	5
		5	185	210	215	25	30	5
		6	180	200	210	20	30	10

1.1        Necropsy

All animals were necropsied. During necropsy, no macroscopic findings were observed.

Table4NecropsyResult

Sex	Dose	ID	Result	Sex	Dose	ID	Result
♀	2000 mg/kg	1	no findings	♀	2000 mg/kg	4	no findings
		2	no findings			5	no findings
		3	no findings			6	no findings

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of the test item N-(4-anilinophenyl)-4-methylbenzenesulfonamide is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item N-(4-anilinophenyl)-4-methylbenzenesulfonamide is classified in GHS Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.