Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Reaction mass of 12-Hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-1,2-Ethanediylbis(12-hydroxyoctadecanamide) and N,N'-1,2-Ethanediylbis[decanamide]

EC Number (omit if confidential): 907-495-0

CAS Number (omit if confidential): 198028-14-7

Date of considerations: 08 December 2021.

• Hazard endpoint for which vertebrate testing was proposed:
Fish early-life stage toxicity study with Reaction mass of 12-Hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-1,2-Ethanediylbis(12-hydroxyoctadecanamide) and N,N'-1,2-Ethanediylbis[decanamide] (EC Number 907-495-0, CAS Number 198028-14-7) 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 long-term toxicity to fish study 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.


Data source

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-
EC Number:
907-495-0
Cas Number:
198028-14-7
Molecular formula:
C90H180N6O9
IUPAC Name:
Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-
Test material form:
solid
Details on test material:
Chemical name : Reaction mass of N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and Decanamide, N,N'-1,2-ethanediylbis-

Chemical registery number : EC 907-495-0 / CAS : 198028-14-7

Results and discussion

Applicant's summary and conclusion