Registration Dossier
Registration Dossier
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EC number: 211-519-9 | CAS number: 657-27-2
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- 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 4.4; Database version: 4.4
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: Cl.NCCCCC(N)C(O)=O
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
- Defined endpoint: Androgen Receptor Binding - Human Health Hazards -> Toxicity to
Reproduction -> AR antagonism -> Homo sapiens
- Defined domain of applicability: The target chemical FALLS within the applicability domain.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- SAR/QSAR prediction
prediction based on Androgen Receptor Antagonism (Human in vitro) - Danish QSAR DB battery
model - GLP compliance:
- no
Test material
- Reference substance name:
- L-Lysine HCl
- IUPAC Name:
- L-Lysine HCl
- Details on test material:
- - Name of test material (as cited in study report): L-Lysine Monohydrochloride
- Molecular formula: C6H14N2O2HCl
- Molecular weight: 182.65
- Substance type: Beige powder with lumps
- Physical state: Solid
- Analytical purity: 99.72%
- Impurities (identity and concentrations): -
- Composition of test material, percentage of components: -
- Isomers composition: -
- Purity test date: -
- Lot/batch No.: 0148
- Expiration date of the lot/batch: 28 May 2012
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: Androgen Receptor Binding
- Effect level:
- other: negative
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: roles in male reproductive development and function and in maintaining female fertility through key roles in the regulation of follicle health, development, and ovulation
- Remarks on result:
- other: The QSAR calculation showed a negative results for reproductive toxicity based on androgen receptor binding. An effect level is not necessary due to high intake through food of this essential nutrient.
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: Androgen Receptor Binding
- Generation:
- F1
- Effect level:
- other: fffnegative
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: roles in male reproductive development and function and in maintaining female fertility through key roles in the regulation of follicle health, development and ovulation
- Remarks on result:
- other: The QSAR calculation showed a negative results for reproductive toxicity based on androgen receptor binding. An effect level is not necessary due to high intake through food of this essential nutrient.
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the QSAR model Androgen Receptor Binding as the endpoint for reproductive toxicity showed a negative result for Lysine-HCl.
- Executive summary:
The Androgen Receptor Antagonism model is suitable for the prediction of reproductive toxicity. The androgen receptor (AR) has defining roles in male reproductive development and function as well as in regulating follicle development and ovulation (Walters K.A., Allan C.M., Handelsman D.J., 2008, BIOLOGY OF REPRODUCTION 78, 380–389).
Therefore, this QSAR prediction together with all available data showed no evidence of reproductive toxicity of L-lysine-HCl.
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