Ethanol, 2-methoxy-, manufacture of, by-products from, esters with boric acid

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Remarks:

based on test guideline (migrated information)

Type of information:

experimental study planned

Study period:

30 months after 1) the receipt of the final ECHA decision on the test proposal or 2) the availability of results from the OECD 408 (90d) and OECD 414 (teratology) studies, whichever is later.

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study will be conducted under GLP and according to internationally accepted testing guidelines. A test proposal for studying fertility, postnataltoxicity and possibly second generation effects is made for B-TEGME, provided that this cannot be replaced by weigth of evidence (read accross) or waiving based upon a tier approach. More information on the toxicology strategy is provided in the attachment 'Toxicology strategy '.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)

Principles of method if other than guideline:

The study will only be performed if really needed, based on the results of the OECD 408 and 414 studies and on the scientific and regulatory evolutions at the time of the ECHA decision on the test proposal. More information is provided in the attached toxicology testing strategy proposal.

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

EC Number:

250-418-4

EC Name:

Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate

Cas Number:

30989-05-0

Molecular formula:

C21H45BO12

IUPAC Name:

tris{2-[2-(2-methoxyethoxy)ethoxy]ethyl} borate

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified