Ethyl 4-dimethylaminobenzoate

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

2 years from ECHA's approval (final decision on TP)

Justification for type of information:

CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION


Public substance name: Ethyl-4-(dimethylamino)benzoate
EC Number (omit if confidential): 233-634-3
CAS Number (omit if confidential): 10287-53-3
Date of considerations: 22 November 2021.


• Hazard endpoint for which vertebrate testing was proposed:
Fish early-life stage toxicity study with Ethyl-4-(dimethylamino)benzoate (EC Number 233-634-3, CAS Number 10287-53-3) according to the OECD Test Guideline 210.


• Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):


• available GLP studies
None


• available non-GLP studies
None


• historical human data
Not relevant


• (Q)SAR
To our knowledge, there is no appropriate QSAR for estimating chronic toxicity with same endpoints as the OECD TG 210.


• in vitro methods
To our knowledge, there is no validated in vitro test method for estimating chronic toxicity with same endpoints as the OECD TG 210.


• weight of evidence
There are not enough available data for a weight of evidence approach.


• grouping and read-across
There are no identified groups of substances or similar substances for a read across approach.


• substance-tailored exposure driven testing [if applicable]


• [approaches in addition to above [if applicable]


• other reasons [if applicable]


• Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable (instruction: free text):


No long-term toxicity to fish data is available for the registered substance. In accordance with the Decision of the Board of Appeal in case A-011-2018, the REACh Annex IX, Section 9.1., Column 2 does not allow omitting the need to submit information on long-term toxicity to fish under Column 1. Therefore, fish long-term toxicity testing is a standard information requirement under annex IX of REACh regulation EC 1907/2006. Therefore, an OECD 210 study is proposed and cannot be waived.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 4-dimethylaminobenzoate

EC Number:

233-634-3

EC Name:

Ethyl 4-dimethylaminobenzoate

Cas Number:

10287-53-3

Molecular formula:

C11H15NO2

IUPAC Name:

ethyl 4-(dimethylamino)benzoate