[No public or meaningful name is available]

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study planned

Study period:

Within the time frame given in the final decision.

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies:
An acute oral study (OECD TG 423) was performed. The results of this study did not result in classification of the registered substance. In order to address the potential effects of the registered substance after repeated exposure, further testing is considered necessary. No GLP repeated study or other study or data found in public literature databases is available to fill the endpoint.
- Available non-GLP studies: No data are available, or found in public literature data bases, to fill in the endpoint.

- Historical human/control data: No human data are available.
- (Q)SAR: QSAR data are not considered sufficient to fill this endpoint.
- In vitro methods: Currently no in vitro systems are available to address this endpoint.
- Weight of evidence: Not applicable, no further data available.
- Grouping and read-across: At this point, no relevant data are available from analogues to further
address this endpoint.
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above: Not applicable
- Other reasons: None

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The study setup based on the most recent version of the OECD Guideline 408 is considered adequate.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Version / remarks:

Latest version

Deviations:

no

Test material

Test material information

Constituent 1

Reference substance name:

N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide

Molecular formula:

C29H27N3O4S

IUPAC Name:

N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: Off-white powder
- Storage condition: At room temperature protected from light

Test animals

Species:

rat