Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

The substance is not teratogenic in rats (OECD 414, GLP) upon oral dosing up the limit dose

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
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

An OECD 414 study was performed on the read across substance L-Glutamic acid, N-coco acylderivs., disodium salts (CAS 68187-30 -4) in order to investigate the developmental toxicity in rats. In accordance with ECHA position ECHA/PR/09/13 as of Sept 15, 2009, the OECD 414 test is a valid waiving argument to waive an OECD 421 screening study.

The read across is considered valid as the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures.  It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different.  On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in the in the field “Attached documents”.

Justification for classification or non-classification

Additional information