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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2019
Reliability:
1 (reliable without restriction)
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
Derek Nexus: 6.0.0, Nexus: 2.2.0

2. MODEL (incl. version number)
Derek Nexus: 6.0.0, Nexus: 2.2.0

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
The prediction was carried out on the main constituents of Centella asiatica dry ext.:
Asiaticoside (CAS n. 16830-15-2; EC n. 240-851-7; SMILE: OC8CC1(C)C(CCC3(C)C1CC=C4C2C(C)C(C)CCC2(CCC34C)C(=O)OC7OC(COC6OC(CO)C(OC5OC(C)C(O)C(O)C5O)C(O)C6O)C(O)C(O)C7O)C(C)(CO)C8O)),
Madecassoside (CAS n. 34540-22-2; EC n. 252-076-1; SMILE: OCC1(C)C(O)C(O)CC2(C)C1C(O)CC4(C)C2CC=C5C3C(C)C(C)CCC3(CCC45C)C(=O)OC8OC(COC7OC(CO)C(OC6OC(C)C(O)C(O)C6O)C(O)C7O)C(O)C(O)C8O)),
Asiatic Acid (CAS n. 464-92-6; ECn. 482-720-9; SMILE: O=C(O)C15CCC(C)C(C)C1C4=CCC2C(C)(CCC3C2(C)CC(O)C(O)C3(C)CO)C4(C)CC5)),
Madecassic Acid (CAS n. 18449-41-7; EC n. not available; SMILE: O=C(O)C15CCC(C)C(C)C1C4=CCC2C(C)(CC(O)C3C(C)(CO)C(O)C(O)CC23C)C4(C)CC5))

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached report

5. APPLICABILITY DOMAIN
See attached report

6. ADEQUACY OF THE RESULT
The chosen prediction software is a recognized tool for QSAR predictions and it is considered suitable for the predicton of Developmental toxicity and Teratogenicity

Data source

Reference
Reference Type:
other: Derek Nexus Prediction Report
Title:
Unnamed
Year:
2019

Materials and methods

Principles of method if other than guideline:
Knowledge Base: Derek KB 2018 1.1

Test material

Constituent 1
Reference substance name:
Hydrocotyle asiatica, ext.
EC Number:
283-640-5
EC Name:
Hydrocotyle asiatica, ext.
Cas Number:
84696-21-9
Molecular formula:
not applicable
IUPAC Name:
Hydrocotyle asiatica, ext.
Test material form:
solid
Specific details on test material used for the study:
The prediction was carried out on the main constituents of Centella asiatica dry ext.:
Asiaticoside (CAS n. 16830-15-2; EC n. 240-851-7)
Madecassoside (CAS n. 34540-22-2; EC n. 252-076-1)
Asiatic Acid (CAS n. 464-92-6; ECn. 482-720-9)
Madecassic Acid (CAS n. 18449-41-7; EC n. not available)

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
other: QSAR results

Results: P1 (second parental generation)

Effect levels (P1)

Remarks on result:
other: QSAR results

Results: F1 generation

Effect levels (F1)

Remarks on result:
other: QSAR results

Results: F2 generation

Effect levels (F2)

Remarks on result:
other: QSAR results

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Any other information on results incl. tables

No alerts were matched for the above mentioned compounds regarding the endpoints of developmental toxicity and Teratogenicity.

Applicant's summary and conclusion

Conclusions:
No alerts were matched regarding the endpoints of developmental toxicity and Teratogenicity for the main constituents of Centella asiatica dry ext.:
Asiaticoside (CAS n. 16830-15-2; EC n. 240-851-7)
Madecassoside (CAS n. 34540-22-2; EC n. 252-076-1)
Asiatic Acid (CAS n. 464-92-6; ECn. 482-720-9)
Madecassic Acid (CAS n. 18449-41-7; EC n. not available)