11-aminoundecanoic acid

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: 11-aminoundecanoic acid
EC Number (omit if confidential): 219-417-6
CAS Number (omit if confidential): 2432-99-7

Date of considerations: 24 November 2022.

• Hazard endpoint for which vertebrate testing was proposed:

Fish early-life stage toxicity study with 11-aminoundecanoic acid (EC Number 219-417-6, CAS Number 2432-99-7) 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 datum for long-term toxicity to fish 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:

11-aminoundecanoic acid

EC Number:

219-417-6

EC Name:

11-aminoundecanoic acid

Cas Number:

2432-99-7

Molecular formula:

C11H23NO2

IUPAC Name:

11-aminoundecanoic acid