N-butyl phenyl ether

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

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: n-butyl phenyl ether
- Name of the substance for which the testing proposal will be used [if different from tested substance]: not applicable

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 - There are no existing GLP studies that adequately address the endpoint.
- Available non-GLP studies - There are no existing non-GLP studies that adequately address the endpoint.
- Historical human/control data - There are no existing historical human data that adequately address the endpoint.
- (Q)SAR - There are no currently validated in silico or (Q)SAR approaches to characterize long term toxicity to fish. Additionally, there are no existing data on suitable analogs that adequately address the endpoint that would allow for such a QSAR model to be generated.
- In vitro methods - There are no currently validated in vitro approaches to characterize long term toxicity to fish.
- Weight of evidence - Due to a lack of GLP and non-GLP studies, adequate data on suitable analogs, historical human data, and (Q)SAR and in vitro methods, it is not possible to synthesis a weight of evidence approach to fulfill the long-term toxicity to fish test requirement.
- Grouping and read-across - There are no existing data on suitable analogs that adequately address the endpoint.
- Substance-tailored exposure driven testing - As the product is a fuel marker, there will be no exposure to water bodies, as the product will be combusted upon final use. However, per recent BoA decisions (for example Case #A-010-2019), Column 2 of Section 9.1. of Annex IX to the REACH Regulation is neither a ‘trigger’ nor a ‘waiver’ for the requirement to submit information on long-term toxicity to fish, regardless of whether or not the chemical safety assessment indicates a need for further testing. Thus, a long-term toxicity to fish test is required.
- 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:
- There are no specific adaptation possibilities outlined in Annex IX for long-term toxicity testing on fish.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The study design and methodology has not been finalized. The material is volatile from water, which will make long-term exposure challenging. It is anticipated that a flow-through or daily renewal system will be needed. However, a long-term toxicity test on aquatic invertebrates is currently underway. The observations and information obtained in the performance of this study will be used to guide the design of the long-term toxicity to fish study to ensure an appropriate study design.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl phenyl ether

EC Number:

214-426-1

EC Name:

N-butyl phenyl ether

Cas Number:

1126-79-0

Molecular formula:

C10H14O

IUPAC Name:

butoxybenzene

Test material form:

solid

Sampling and analysis

Analytical monitoring:

yes

Study design

Test type:

other: A flow through or daily renewal system will need to be used due to the volatility of the substance from water.

Water media type:

freshwater