4-(4-isopropoxyphenylsulfonyl)phenol

Developmental toxicity / teratogenicity

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: 4-[4-(propan-2-yloxy)benzenesulfonyl]phenol
CAS number: 95235-30-6
EC number: 405-520-5

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.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

4-(4-isopropoxyphenylsulfonyl)phenol

EC Number:

405-520-5

EC Name:

4-(4-isopropoxyphenylsulfonyl)phenol

Cas Number:

95235-30-6

Molecular formula:

C15H16SO4

IUPAC Name:

4-[4-(propan-2-yloxy)benzenesulfonyl]phenol

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage