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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
reproductive toxicity, other
Remarks:
QSAR
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2017/11/23
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:
please refer to 'attached justification'
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2017/11/23
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:
please refer to 'attached justification'
Reason / purpose for cross-reference:
reference to same study
Guideline:
other: REACH Guidance on QSARs R. 6
Principles of method if other than guideline:
- Software tool(s) used including version: DART scheme v1.1
- Model(s) used: OECD QSAR Toolbox v4.1
- Model description: see field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'
Species:
other: not applicable
Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for teratogenicity based on DART scheme
Abnormalities:
not specified
Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for teratogenicity based on DART scheme
Abnormalities:
not specified
Developmental effects observed:
no
Treatment related:
not specified
Conclusions:
No structural feature associated with teratogenic mode of action was identified in the query chemical by the DART scheme.
Executive summary:

Teratogenicity of 6-amino-1,3 -dimethyluracil was assessed using the rule-based SAR DART scheme v1.1, which is implemented in the OECD QSAR Toolbox v4.1. No structural feature associated with teratogenic mode of action was identified in the query chemical. This gives weight of evidence that DIMAU is not teratogenic.

Data source

Referenceopen allclose all

Reference Type:
other: SAR
Title:
DART scheme v1.1
Author:
Procter and Gamble, LMC OASIS
Year:
2013
Bibliographic source:
This SAR identifies chemical structures known to be developmental and reproductive toxic (DART), or that it is not associated with chemical structures known to be develobmental and reproductive toxic (DART).
Reference Type:
publication
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Guideline:
other: REACH Guidance on QSARs R. 6
Principles of method if other than guideline:
- Software tool(s) used including version: DART scheme v1.1
- Model(s) used: OECD QSAR Toolbox v4.1
- Model description: see field 'Attached justification'
- Justification of QSAR prediction: see field 'Attached justification'

Test material

Constituent 1
Chemical structure
Reference substance name:
6-amino-1,3-dimethyluracil
EC Number:
229-662-0
EC Name:
6-amino-1,3-dimethyluracil
Cas Number:
6642-31-5
Molecular formula:
C6H9N3O2
IUPAC Name:
6-amino-1,3-dimethylpyrimidine-2,4(1H,3H)-dione

Test animals

Species:
other: not applicable

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for reproductive based on DART scheme

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: P1 (second parental generation)

Effect levels (P1)

Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for reproductive based on DART scheme

Target system / organ toxicity (P1)

Critical effects observed:
not specified

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for reproductive based on DART scheme

Target system / organ toxicity (F1)

Critical effects observed:
not specified

Results: F2 generation

Effect levels (F2)

Dose descriptor:
other: QSAR
Remarks on result:
other: see Remarks
Remarks:
no indication for reproductive based on DART scheme

Target system / organ toxicity (F2)

Critical effects observed:
not specified

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
No structural feature associated with a mode of action associated with reproductive toxicity was identified in the query chemical by the DART scheme.
Executive summary:

Reproductive toxicity of 6 -amino-1,3 -dimethyluracil was assessed using the rule-based SAR DART scheme v1.1, which is implemented in the OECD QSAR Toolbox v4.1. No structural feature associated with a mode of action associated with reproductive toxicity was identified in the query chemical. This gives weight of evidence that DIMAU is not toxic to reproduction.