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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
As the three QSAR predictions provided information sufficient for classification and labelling purposes, but do not indicate effect levels, the database is limited but of sufficient quality.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The reproductive toxicity of the registered substance (a multi-constituent substance) was evaluated using a read-across approach of the two main constituents, using bespoke QSARs created in the OECD QSAR Toolbox which were tailored to both the substance and the endpoint. Suitable analogues were found using the DART v1.0 category and the results refined using relevant subcategories. Where the bespoke model was found to be inconclusive, the constituent was evaluated again using the reproductive and developmental toxicity model pre-defined in the OECD QSAR Toolbox.

Both constituents were predicted to have no known precedent for reproductive potential.


Short description of key information:
Toxicity to reproduction: Not known precedent reproductive potential, QSAR, Disodium N-(1-oxohexadecyl)-L-glutamate
Toxicity to reproduction: Not known precedent reproductive potential, QSAR, Disodium N-(1-oxooctadecyl)-L-glutamate

Justification for selection of Effect on fertility via oral route:
As the registered substance is a multiconstituent substance, the reproductive toxicity was assessed using QSAR predictions of the two main constituents. All reports were therefore selected as key.

Effects on developmental toxicity

Description of key information
Developmental toxicity: Not known precedent reproductive and developmental toxicity potential, QSAR, Disodium N-(1-oxohexadecyl)-L-glutamate
Developmental toxicity: Not known precedent reproductive and developmental toxicity potential, QSAR, Disodium N-(1-oxooctadecyl)-L-glutamate
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
As the three QSAR predictions provided information sufficient for classification and labelling purposes, but do not indicate effect levels, the database is limited but of sufficient quality.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The developmental toxicity of the registered substance (a multi-constituent substance) was evaluated using a read-across approach of the two main constituents, using bespoke QSARs created in the OECD QSAR Toolbox which were tailored to both the substance and the endpoint. Suitable analogues were found using the DART v1.0 category and the results refined using relevant subcategories. In order to remain consistent with the approach taken for modelling the reproductive toxicity, the hexa constituent was also evaluated using the reproductive and developmental toxicity model pre-defined in the OECD QSAR Toolbox.

Both constituents were predicted to have no known precedent for developmental potential.


Justification for selection of Effect on developmental toxicity: via oral route:
As the registered substance is a multiconstituent substance, the developmental toxicity was assessed using QSAR predictions of the two main constituents. All reports were therefore selected as key.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008 (CLP), the substance does not require classification with respect to reproductive or developmental toxicity.

Additional information