Registration Dossier
Registration Dossier
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EC number: 605-637-3 | CAS number: 172529-93-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.09.2007 - 20.10.2007
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate
- Cas Number:
- 172529-93-0
- Molecular formula:
- C12 H14 Cl N5 O4
- IUPAC Name:
- 1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate
- Reference substance name:
- 2-Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate- 4-yl)purine
- IUPAC Name:
- 2-Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate- 4-yl)purine
- Details on test material:
- Formula: C12H14ClN5O4
Appearance: White to pale yellow solid
Expiry date: 31 December 2007
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- (low dose): 5% (w/w) test substance
(mid dose): 10% (w/w) test substance
(high dose): 21.9% (w/w) test substance - No. of animals per dose:
- 3 goups of 5 fenale per dose
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: group K (negative control) SI: 1 group A (low dose) SI: 1.4 group B (mid dose) SI: 2.0 group C (high dose) SI: 3.2 group P (positive control) SI: 9.5
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: group K (negative control) DPM: 2948 group A (low dose) DPM: 4251 group B (mid dose) DPM: 5953 group C (high dose) DPM: 9289 group P (positive control) DPM: 28043
Any other information on results incl. tables
The positive control substance led to a stimulation index of 9.5, thus demonstrating the validity of the experiment.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the OECD-Guideline 429 and the REGULATION (EC) No 1272/2008., "Fam-stage-1" is regarded as a sensitiser in the LLNA.
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