Registration Dossier

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.