Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

screening for reproductive / developmental toxicity
Type of information:
experimental study planned (based on read-across)
Justification for type of information:
See "Attached justification"

Data source

Materials and methods

Test guideline
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
{[(2-hydroxyethyl)carbamoyl]methyl}dimethyl(3-octadecanamidopropyl)azanium chloride

Results and discussion

Applicant's summary and conclusion

Based on this feasibility study including:
- the search for similar chemical structures (analogues);
- the bibliographic research on the selected structures;
- the pre-validation of identified data that could be used on these analogues;
it is concluded that a Weight of Evidence can be prepared to fulfil the data gap concerning the endpoint of reprotoxicity.
This approach can be built on existing data on similar substances representing structural parts and potential metabolites of MONTALINE C40 (analogue approach).