Registration Dossier

Toxicological information

Toxicity to reproduction

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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 placed 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 for B-TEGME is provided in the attachment 'B-TEGME Toxicology strategy '.

Data source

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion