Registration Dossier

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Study period:
2019
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : tert-butyl peroxybenzoate
- Name of the substance for which the testing proposal will be used [if different from tested substance] : same as above

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: none
- Available non-GLP studies: none
- Historical human data: not applicable
- (Q)SAR: not reliable for aquatic endpoints for this substance (comparison of ECOSAR results with reliable REACH data for other aquatic endpoints)
- In vitro methods: not applicable
- Weight of evidence: none available
- Grouping and read-across: none available
- Substance-tailored exposure driven testing [if applicable] : not applicable
- Approaches in addition to above [if applicable]: not applicable
- Other reasons [if applicable]: 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:
- based on the current PNECs and global product stewardship concerns regarding safe global manufacturing / environmental assessments at all global sites, there is a need to start this study as soon as possible in an attempt to improve the PNECs and ensure safe global manufacturing of the substance.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: standard OECD 210

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion