Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
There are no GLP, non-GLP studies nor any historical human data for the registered substance available. Application of grouping, read-across and (Q)SAR is difficult due to the complex composition of the material (UVCB). Furthermore, the registrant is not aware of any In vitro method which can fulfil data requirements for this endpoint. There are no studies which can be used in combination to fullfil data requirements using weight of evidence approach. Substance-tailored exposure driven testing is not applicable for the registered substance and relevant uses.
According to Annex VIII, the OECD 414 prenatal toxicity study is required for compounds with an average tonnage band of >=100 t. Hence, we propose an oral OECD 414 study with rats.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
Reference substance name:
{2-[(2-aminoethyl)amino]ethyl}(benzyl)amine
Cas Number:
39549-34-3
Molecular formula:
C11H19N3
IUPAC Name:
{2-[(2-aminoethyl)amino]ethyl}(benzyl)amine
Constituent 2
Chemical structure
Reference substance name:
benzyl(2-{[2-(benzylamino)ethyl]amino}ethyl)amine
Cas Number:
17327-80-9
Molecular formula:
C18H25N3
IUPAC Name:
benzyl(2-{[2-(benzylamino)ethyl]amino}ethyl)amine
Constituent 3
Chemical structure
Reference substance name:
Piperazine-1,4-diethylamine
EC Number:
229-428-8
EC Name:
Piperazine-1,4-diethylamine
Cas Number:
6531-38-0
Molecular formula:
C8H20N4
IUPAC Name:
2,2'-piperazine-1,4-diyldiethanamine
Constituent 4
Chemical structure
Reference substance name:
2-piperazin-1-ylethylamine
EC Number:
205-411-0
EC Name:
2-piperazin-1-ylethylamine
Cas Number:
140-31-8
Molecular formula:
C6H15N3
IUPAC Name:
2-piperazin-1-ylethanamine
Constituent 5
Chemical structure
Reference substance name:
N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethylenediamine
EC Number:
244-734-1
EC Name:
N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethylenediamine
Cas Number:
22029-44-3
Molecular formula:
C13H24N4
IUPAC Name:
N-(2-aminoethyl)-N'-[2-(benzylamino)ethyl]ethane-1,2-diamine
Constituent 6
Chemical structure
Reference substance name:
2-{4-[(benzylamino)methyl]piperazin-1-yl}ethan-1-amine
Molecular formula:
C14H24N4
IUPAC Name:
2-{4-[(benzylamino)methyl]piperazin-1-yl}ethan-1-amine
Constituent 7
Chemical structure
Reference substance name:
[2-(benzylamino)ethyl][2-(piperazin-1-yl)ethyl]amine
Molecular formula:
C15H26N4
IUPAC Name:
[2-(benzylamino)ethyl][2-(piperazin-1-yl)ethyl]amine
Constituent 8
Chemical structure
Reference substance name:
1,12-diphenyl-2,5,8,11-tetraazadodecane
Cas Number:
140840-03-5
Molecular formula:
C20H30N
IUPAC Name:
1,12-diphenyl-2,5,8,11-tetraazadodecane
Constituent 9
Chemical structure
Reference substance name:
benzyl(2-{4-[2-(benzylamino)ethyl]piperazin-1-yl}ethyl)amine
Cas Number:
176906-02-8
Molecular formula:
C22H32N4
IUPAC Name:
benzyl(2-{4-[2-(benzylamino)ethyl]piperazin-1-yl}ethyl)amine
Test material form:
liquid: viscous

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion