Registration Dossier
Registration Dossier
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EC number: 221-678-6 | CAS number: 3184-13-2
Toxicity to reproduction
Administrative data
- 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 (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
L-(+)-2,5-diaminopentanoic acid is present as L-ornithine under physiological conditions. L-ornithine is one of the substances in the urea cycle and is subject to homeostasis. This means that, in physiological situations, concentrations of L-ornithine vary within fixed limits and are tightly regulated. Exposure from uses which are covered by this registration would only marginally increase the total daily L-ornithine dose which is taken up via the food and would not result in increased systemic concentrations in humans. Therefore it is highly unlikely that L-ornithine taken up via any use covered by this registration would result in any effect on the reproductive system or the unborn life. Taking this into consideration and for animal welfare reasons it is not justified to do any further animal testing with regard to the toxicological endpoints reproductive toxicity and developmental toxicity/teratogenicity.
Notes:
L-ornithine does not enhance the growth of transplantable colon tumor.
L-ornithine is considered as safe ('no saftey concern" as a food additive.
Literature:
B. Grossie Jr., K. Nishioka, J. Ajani and D. Ota (1992): Substituting Ornithine for Arginine in Total Parental Nutrition Elimantes Enhanced Tumor Growth. Journal of Surgical Oncology 50, 161-167
WHO Technical Report Series (2014): Evaluation of certain food additives. Seventy-sixth report of the Joint FAO/WHO Expert Committee on Food Additives
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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