Registration Dossier

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: (octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate
EC Number: 255-901-3
CAS Number: 42594-17-2

Date of considerations: 23 February 2021.

• Hazard endpoint for which vertebrate testing was proposed:

Fish early-life stage toxicity study with (octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate (EC Number 255-901-3, CAS Number 42594-17-2) 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.

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:
(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate
EC Number:
255-901-3
EC Name:
(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate
Cas Number:
42594-17-2
Molecular formula:
C18H24O4
IUPAC Name:
octahydro-1H-4,7-methanoindene-1,1-diylbis(methylene) bisacrylate

Results and discussion

Applicant's summary and conclusion

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