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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Justification for type of information:
CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION

Public substance name: Isodecyl methacrylate or IDMA
EC Number: 249-978-2
CAS Number: 29964-84-9

• Hazard endpoint for which vertebrate testing was proposed:
Fish early-life stage toxicity study with Isodecyl methacrylate or IDMA (EC 249-978-2 ) according to the OECD Test Guideline 210.

• 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. No acute toxicity data for daphnia are available to compare sensitivity between the three trophic levels. Additionally, the acute toxicity study conducted with fish is limited as well as it only investigated the effects of a static saturated solution.

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

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

No long-term toxicity to fish study is available for the registered substance.

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)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Isodecyl methacrylate
EC Number:
249-978-2
EC Name:
Isodecyl methacrylate
Cas Number:
29964-84-9
Molecular formula:
C14H26O2
IUPAC Name:
2-methylnonyl 2-methylprop-2-enoate
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion