(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

Awaiting ECHA approval

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: 4 January 2021

Hazard endpoint for which vertebrate testing was proposed:
Reproductive toxicity (oral pre-natal developmental toxicity in rats, OECD TG no. 414) with the registered substance;

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information

• available GLP studies: None.

• available non-GLP studies: None.

• historical human data: None.

• (Q)SAR
According to ECHA guidance R.7a (October 2015, page 382), QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction.

• in vitro methods
In vitro reproduction studies are not available on the test substance.
Some in vitro test methods have been developped, however, according to Chapter R 7a (October 2015, page 381), the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information.

• weight of evidence: No data is available which allow a weight of evidence approach.

• grouping and read-across: No data is available which allow a read across approach.

• substance-tailored exposure driven testing [if applicable]: Not applicable

• [approaches in addition to above [if applicable] : Not applicable

• other reasons [if applicable] :None


Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Test proposal is fully compliant with ECHA guidance R 7.a (Oct 2015, page 373). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Esterification product of poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.'-(2,2-dimethyl-1,3-propanediyl)bis[.omega.-hydroxy- and prop-2-enoic acid

EC Number:

617-546-6

Cas Number:

84170-74-1

Molecular formula:

(C3H6O)x (C3H6O)y C11H16O4

IUPAC Name:

Esterification product of poly[oxy(methyl-1,2-ethanediyl)], .alpha.,.alpha.'-(2,2-dimethyl-1,3-propanediyl)bis[.omega.-hydroxy- and prop-2-enoic acid

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage