Registration Dossier
Registration Dossier
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EC number: 200-254-4 | CAS number: 56-06-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary source
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,6-diamino-1H-pyrimidin-4-one
- EC Number:
- 200-254-4
- EC Name:
- 2,6-diamino-1H-pyrimidin-4-one
- Cas Number:
- 56-06-4
- Molecular formula:
- C4H6N4O
- IUPAC Name:
- 2,6-diamino-1H-pyrimidin-4-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone (for challenge)
- Concentration / amount:
- Induction:
Induction Concentration: 5%, 2.5%, 1.0% and 0.5%
Intradermal injection: 2.5%
Topical:100%
Challenge
2.5, 50, 75 and 100 mg moistened with acetone
Challengeopen allclose all
- Route:
- other: epicutaneous, not specified
- Vehicle:
- other: acetone (for challenge)
- Concentration / amount:
- Induction:
Induction Concentration: 5%, 2.5%, 1.0% and 0.5%
Intradermal injection: 2.5%
Topical:100%
Challenge
2.5, 50, 75 and 100 mg moistened with acetone
- No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- For the topical induction phase, the skin was treated with sodium lauryl sulfate
- Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100mg
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100mg. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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