N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Remarks:

In accordance with Annex IX of REACH, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(d).

Study period:

A study will be placed after the final decision for this testing proposal is received from the European Chemicals Agency.

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:
N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea

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 only short-term toxicity data on fish conducted in accordance with GLP available. This available study is not suitable to fulfil this information requirement under REACH.
- Available non-GLP studies: There are no available non-GLP studies to address this endpoint.
- Historical human data: Not applicable for this endpoint.
- (Q)SAR: QSAR modelling is not appropriate for this type of substance were the water solubility is very low.
- In vitro methods: None suitable which are able to meet the requirements of this endpoint.
- Weight of evidence: There are no data available to produce a weight-of evidence approach.
- Grouping and read-across: There are no OECD TG 210 studies or other long-term toxicity to fish available on other substances which could be consider for the purposes of read-across or grouping

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:
- There is no Column 2 Annex IX adaptation to waive the OECD TG 210 study. This was clarified by changes to the REACH Annexes following a decision from the Board of Appeal.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed:
The proposed study will be conducted in accordance with OECD TG 210. The study will be conducted as a semi-static or flow-through study depending on the technical input from the test laboratory. It is proposed that the study will be performed on Japanese Medaka as this was the test species used for short-term toxicity testing.

Materials and methods

Test guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Test material information

Constituent 1

Reference substance name:

N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea

EC Number:

876-151-9

Cas Number:

2292123-68-1

Molecular formula:

C27H24N2O7S2

IUPAC Name:

N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea

Test material form:

solid: particulate/powder

Test organisms

Test organisms (species):

Oryzias latipes