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Diss Factsheets
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EC number: 200-292-1 | CAS number: 56-85-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
A 13 week study on oral toxicity is available (see section 7.5). For the oral route a NOAEL of 1.25% diet (833 mg/kg/d) was estimated in a sub-chronic toxicity study. A supporting acute oral toxicity study supports the low systemic toxicity. A study on a higher tier exists, thus a study on a lower tier is not required.
The acute inhalation study and the acute dermal study were waived based on the physico-chemical and toxikokinetic properties.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity study was waived, because a 13-week oral toxicity GLP guideline study of L-glutamine with rats is available (see section 7.5). The feeding of L-glutamine was not associated with overt signs of toxicity. Infrequent changes were witnessed in the urinalysis and blood chemistry in the 2.5% and 5.0% (w/w) groups. All of those changes were determined toxicologically insignificant. No effects of the administration were observed in the 1.25% (w/w) group. Therefore, the definitive toxic Ievel for L-glutamine was determined to be above 5.0% (w/w), and the no-observed-adverse-effect Ievel (NOAEL) was estirnated at 1.25% (w/w) for both genders (males 0.83 ± 0.01 g/kg/day; females, 0.96 ± 0.06 g/kg/day). This GLP guideline study was selected as key study for repeated dose toxicity (see section 7.5).
An acute oral toxicity study was performed with groups of 5 male and 5 female rats. The results of this supporting indicate that the median lethal oral dose (LD 50) of L-glutamine is ca. 16g/kg bw.These results show that the toxicity of L-glutamine via the oral route is extremely low. The absence of acute toxic effects even at application of increased value doses indicates a low systemic toxicity of L-glutamine.
Inhalation is not a relevant route based upon the vapour pressure and particle size (granulometry) of L-glutamine.
No data on acute dermal toxicity for L-glutamine is available. Due to its very low systemic toxicity and the fact that L-glutamine (with high water solubility and a log P value well below 0) may be too hydrophilic to cross the lipid rich environment of the stratum corneum it is highly improbable that an acute dermal toxicity study would result in any toxicity.
Justification for selection of acute toxicity – oral endpoint
A 13 week study on oral toxicity is available (see section 7.5). For the oral route a NOAEL of 1.25% diet (833 mg/kg/d) was estimated in a sub-chronic toxicity study. A supporting acute oral toxicity study supports the low systemic toxicity. A study on a higher tier exists, thus a study on a lower tier is not required.
Justification for classification or non-classification
Based on the data available no classification for acute toxicity (oral toxicity, dermal toxicity, inhalation toxicity) is required.
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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