N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Type of information:

experimental study planned

Study period:

to be determined by ECHA

Justification for type of information:

TESTING PROPOSAL ON VETEBRATE ANIMALS:

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: Prenatal Development Toxicity study (oral gavage, rat) crf. OECD 414 (performed in 1985).
- Available non-GLP studies: no non GLP studies which are relevant for this endpoint
- Historical human data: no human data are available which can provide input for this endpoint
- (Q)SAR: no QSARs were performed for this endpoint
- In vitro methods: not available for this endpoint
- Weight of evidence: not available for this endpoint
- Grouping and read-across: not available for this endpoint

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The registrant submitted a waiver for performing this test in its dossier : "A developmental toxicity study in a second species will not be performed. The substance was demonstrated to display no significant adverse effects in a two-generation toxicity study in rats or in a prenatal developmental toxicity study in rats. Therefore, it is deemed unlikely that a prenatal development toxicity study in a second species would have added value." This was not accepted by the ECHA. Therefore, the registrant doesn't see another option apart from performing the PND test in a second species.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: OECD 414 will be performed in rabbits.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)

GLP compliance:

yes (incl. QA statement)

Justification for study design:

SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS:

- Premating exposure duration for parental (P0) animals : cfr. OECD guideline
- Basis for dose level selection: to be confirmed, based on available information (repeated dose studies)
- Exclusion of developmental neurotoxicity Cohorts 2A and 2B: no particular concerns identified. Therefore, suggested not to include additional cohorts.
- Exclusion of developmental immunotoxicity Cohort 3: no particular concerns identified. Therefore, suggested not to include additional cohorts.
- Route of administration: oral
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals [if applicable]: rat

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)

EC Number:

221-220-5

EC Name:

N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)

Cas Number:

3033-62-3

Molecular formula:

C8H20N2O

IUPAC Name:

{2-[2-(dimethylamino)ethoxy]ethyl}dimethylamine

Test material form:

liquid

Administration / exposure

Route of administration:

oral: gavage

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:

not specified