Sodium hydrogen N-(1-oxotetradecyl)-L-glutamate

Endpoint summary

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 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 cahpter 13 of Iuclid.