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Toxicological information

Toxicity to reproduction

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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:
2022
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

Constituent 1
Chemical structure
Reference substance name:
L-glutamine
EC Number:
200-292-1
Cas Number:
56-85-9
Molecular formula:
C5H10N2O3
IUPAC Name:
L-glutamine

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.