Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Repeated dose oral toxicity: NOEL ca. 803.3 mg/kg bw/day (oral gavage, rats), QSAR, Disodium N-(1-oxohexadecyl)-L-glutamate
Repeated dose oral toxicity: NOEL ca. 431.7 mg/kg bw/day (oral gavage, rats), QSAR, Disodium N-(1-oxooctadecyl)-L-glutamate
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The database is limited but of sufficient quality. The two QSAR predictions provided NOELs which can be used as a basis for classification and labelling, and also for risk assessment purposes, but does not indicate effects on specific organs.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The repeat dose oral 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, tailored to both the substance and the endpoint. Suitable analogues were found using the Repeated Dose Hess category and the results refined using relevant subcategories.
The repeated dose oral toxicity No Observed Effect Level (NOEL) of disodium N-(1-oxohexadecyl)-L-glutamate was determined to be ca. 803.3 mg/kg bw/day in the rat via oral gavage. The oral gavage NOEL in rats for disodium N-(1-oxooctadecyl)-L-glutamate was determined to be ca. 431.7 mg/kg bw/day.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
As the registered substance is a multiconstituent substance, the repeated dose toxicity was assessed using QSAR predictions of the two main constituents. As both reports demonstrated high expected No Observed Effect Levels (NOELs), both were presented as key studies.
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 Specific Target Organ Toxicity repeated dose (STOT RE) via the oral route.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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