Registration Dossier
Registration Dossier
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EC number: 214-275-1 | CAS number: 1119-34-2
Toxicity to reproduction
Administrative data
- 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: NC(CCCNC(N)=N)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
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
- 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
Test material
- Reference substance name:
- Levoglutamide
- EC Number:
- 200-292-1
- EC Name:
- Levoglutamide
- Cas Number:
- 56-85-9
- Molecular formula:
- C5H10N2O3
- IUPAC Name:
- L-glutamine
Constituent 1
Administration / exposure
- Details on study design:
- Data gap filling method: Read-across analysis, Human Health Hazards -> Toxicity to Reproduction -> AR antagonism -> Homo sapiens
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- other: Predicted value: Negative
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: AR antagonism; Androgen Receptor Binding
- Remarks on result:
- not measured/tested
- Remarks:
- results derived from a valid (Q)SAR model and falling into its applicability domain
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- other: Predicted value: Negative
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- not measured/tested
- Remarks:
- results derived from a valid (Q)SAR model and falling into its applicability domain
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- QSAR predicts that toxicity to reproduction is negative for L-Arginine.
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