Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Key value for chemical safety assessment
Effects on fertility
Description of key information
L-Glutamine did not show effects on the reproductive organs in general repeated dose toxicity studies. Furthermore, a QSAR predicts no toxicity to reproduction.
Moreover, L-glutamine is an amino acid that is required for normal functioning of humans. The substance is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic effects are not expected for L-glutamine and no test is required for this substance.
There is sufficient weight of evidence for the absence of reprotoxic effects. A screening for reproductive toxicity (REACH Annex VIII No. 8.7.1) as well as any study on reproductive toxicity as REACH Annex IX no. 8.7 are not to be conducted in accordance with REACH Annex XI no. 1.2. and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE: QSAR Toolbox 4.5
2. MODEL (incl. version number): Androgen Receptor Antagonism (Human in vitro) - Danish QSAR DB battery model (v.1.0)
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL: N[C@H](CCC(N)=O)C(O)=O
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
- Defined endpoint: AR antagonism; Androgen Receptor Binding
5. APPLICABILITY DOMAIN: The target chemical FALLS within the applicability domain, please see report attached - Principles of method if other than guideline:
- SAR/QSAR prediction: Calculation based on QSAR Toolbox 4.5. model: Androgen Receptor Antagonism (Human in vitro) - Danish QSAR DB battery model (v.1.0)
- GLP compliance:
- no
- Details on study design:
- Data gap filling method: Read-across analysis, Human Health Hazards -> Toxicity to
Reproduction -> AR antagonism -> Homo sapiens - Remarks on result:
- other: Predicted value: Negative
- Remarks on result:
- other: Predicted value: Negative
- Reproductive effects observed:
- no
- Conclusions:
- QSAR predicts that toxicity to reproduction is negative for L-Glutamine.
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
L-Glutamine did not show effects on the reproductive organs in general repeated dose toxicity studies. Furthermore, a QSAR for the endpoint reproductive toxicity predicts no toxicity to reproduction.
Moreover, L-glutamine is an amino acid that is required for normal functioning of humans. The substance is of low toxicological activity and subject to homeostasis.
A significant amount of L-glutamine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated.
Exposure with L-glutamine from uses which are covered by this registration would only marginally increase the total daily L-glutamine dose which is taken up via the food. Even if the plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis.
Several repeated dose toxicity studies consistently indicate the very low toxicity of L-glutamine. Even in very high doses no toxicity is observed and no adverse effects were reported for the reproductive organs. Therefore, reprotoxic effects are not expected for L-glutamine and no test is required for this substance.
There is sufficient weight of evidence for the absence of reprotoxic effects. A screening for reproductive toxicity (REACH Annex VIII No. 8.7.1) as well as any study on reproductive toxicity as REACH Annex IX no. 8.7 are not to be conducted in accordance with REACH Annex XI no. 1.2. and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..." - Reproductive effects observed:
- not specified
Referenceopen allclose all
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
There are no studies for reproductive toxicity/developmental toxicity of L-glutamine accessible to the registrant.
L-Glutamine did not show effects on the reproductive organs in general repeated dose toxicity studies. Furthermore, a QSAR predicts no toxicity to reproduction.
Moreover, L-glutamine is an amino acid that is required for normal functioning of humans. The substance is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic effects are not expected for L-glutamine and no test is required for this substance.
A significant amount of L-glutamine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated.
Exposure with L-glutamine from uses which are covered by this registration would only marginally increase the total daily L-glutamine dose which is taken up via the food. Even if the plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis.
Several repeated dose toxicity studies consistently indicate the very low toxicity of L-glutamine. Even in very high doses no toxicity is observed and no adverse effects were reported for the reproductive organs.
Therefore it is highly unlikely that L-glutamine taken up via any use covered by this registration would result in systemic effects including effects on unborn life.
Short description of key information:
It is not expected that L-glutamine does affect fertility. No test is required for this substance.
Effects on developmental toxicity
Description of key information
There are no studies for reproductive toxicity/developmental toxicity of L-glutamine accessible to the registrant.
L-Glutamine did not show effects on the reproductive organs in general repeated dose toxicity studies. Furthermore, a QSAR predicts no toxicity to reproduction.
Moreover, L-glutamine is an amino acid that is required for normal functioning of humans. The substance is of low toxicological activity and subject to homeostasis. Therefore, reprotoxic effects are not expected for L-glutamine and no test is required for this substance.
A significant amount of L-glutamine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated.
Exposure with L-glutamine from uses which are covered by this registration would only marginally increase the total daily L-glutamine dose which is taken up via the food. Even if the plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis.
Several repeated dose toxicity studies consistently indicate the very low toxicity of L-glutamine. Even in very high doses no toxicity is observed and no adverse effects were reported for the reproductive organs.
Therefore it is highly unlikely that L-glutamine taken up via any use covered by this registration would result in systemic effects including effects on unborn life.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
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
Regarding reproductive toxicity/developmental toxicity no study reports for L-glutamine are accessible to the registrant. L-Glutamine did not show effects on the reproductive organs in general repeated dose toxicity studies. Furthermore, a QSAR predicts no toxicity to reproduction. A significant amount of L-glutamine is usually taken up via the food. In usual diet, most amino acids are supplied as constituents of protein and not as free amino acid. Protein intake clearly modifies plasma amino acid levels. However, amino acid concentrations are subject to homeostasis and the plasma concentrations vary within fixed limits and are tightly regulated. Exposure with L-glutamine from uses which are covered by this registration would only marginally increase the total daily L-glutamine dose which is taken up via the food. Even if the
plasma amino acid concentration would increase/vary by any use such fluctuations are physiological and subject to homeostasis. Therefore it is highly unlikely that L-glutamine taken up via any use covered by this registration would result in systemic effects including effects on unborn life.
There is sufficient weight of evidence for the absence of developmental toxicity / teratogenicity. Any study on developmental toxicity / teratogenicity as REACH Annex IX no. 8.7 are not to be conducted in accordance with REACH Annex XI no. 1.2. and for reasons of animal welfare: "Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available, further testing on vertebrate animals for this property shall be omitted..."
Justification for classification or non-classification
There is no indication that L-glutamine causes toxicity to reproduction. Thus, classification as to reproductive toxicity according to EU-GHS is not required.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.