Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
After approval by ECHA
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:
IUPAC name: N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
CAS number: 215917-77-4

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: There are no GLP studies available covering pre-natal developmental toxicity study information requirements.
- Available non-GLP studies: There are no non-GLP studies available covering pre-natal developmental toxicity information requirements.
- Historical human data: There are no historical human data available on pre-natal developmental toxicity study for the substance.
- (Q)SAR: At present there is no valid (Q)SAR model available to address pre-natal developmental toxicity. (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance)
- In vitro methods: At present there are no valid in vitro methods available to address pre-natal developmental toxicity. (ECHA Guidance in Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance)
- Weight of evidence: There are no data available which are sufficient for weight of evidence approach.
- Grouping and read-across: No substances or a category of substances are known which apply for read across addressing pre-natal developmental toxicity study.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable

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:
According to Column 2 Annex IX of REACH Regulation a pre-natal developmental toxicity study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data.
In order to fulfill information requirements stated in column 1 Annex IX of REACH Regulation for substances manufactured or imported in quantities of 100 tpa or more, a pre-natal developmental toxicity study is proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design: The proposed study will be performed in rats which will receive the test item via oral gavage according OECD TG 414.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide
EC Number:
806-543-7
Cas Number:
215917-77-4
Molecular formula:
C19H17N3O3S
IUPAC Name:
N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion