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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

No reproductive toxicity

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because a pre-natal developmental toxicity study is available
other:
Justification for type of information:
Key human reproductive processes such as ovarian folliculo genesis, oocyte maturation
and preimplantation embryo development are more closely related to bovine than to laboratory rodents. Bovine in vitro tests are based on protocols that mirror those used in assisted
reproduction and are therefore particularly suitable to reveal toxic effects. No animal
sacrifice is needed because bovine oocytes can be collected in large numbers from animals already destined to enter the food chain and bovine semen is commercially available as frozen product. This in vitro test proved that substance is not toxic for reproduction as well as source substace used for OECD 414. The in vitro study also verified reproductive toxicity of different acyl glutamates (bridging approach). More information can be found in the Read Across Report in chapter 13 of Iuclid.
Reason / purpose for cross-reference:
reference to other study
Reason / purpose for cross-reference:
read-across source
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
Additional information

A bovine oocytes in vitro maturation test (bIVM) was performed on the substance. According to the test the substance has no reproductive toxicity. The test was also performed on the source substance used for OECD 414 showing same behaviour.


 

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 source substance L-Glutamic acid, N-coco acylderivs., disodium salts (CAS 68187-30 -4) in order to investigate the developmental toxicity in rats. An in vitro reprotox test was performed on source and target substance to demonstare that target sibstamce is not toxic to reproduction and has same behabviour as source substance.


The read across is considered valid as the target substance is one  component 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 cahpter 13 of Iuclid.

Justification for classification or non-classification

Additional information