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EC number: 440-560-7 | CAS number: 346709-25-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-560-7
- EC Name:
- -
- Cas Number:
- 346709-25-9
- Molecular formula:
- Unspecified
- IUPAC Name:
- 2,6,8-triamino-4H,10H-pyrimido[5,4-g]pteridin-4-one; pyrimido[5,4-g]pteridine-2,4,6,8-tetramine
- Details on test material:
- - Description: Yellow solid
- Batch: MAF 382/053
- Purity: 94.8 %
- Test substance storage: at room temperature in the dark
- Stability under storage conditions: stable
- Expiry date: 06 November 2005
- Stability in vehicle - Water: at least 4 h
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany)
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams of the test substance
- Concentration (if solution): the test substance was moistened with 0.6 ml of the vehicle and applied to the skin of one flank - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after the removal of the dressings and test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: metalline patch which was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: dressing was removed and the skin cleaned of residual test substance using water
- Time after start of exposure: 4 hours
SCORING SYSTEM: OECD Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
Any other information on results incl. tables
Table 1: Individual skin irritation scores
| Exposition: | 4 h | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 1 h | 1 | 1 | Yellow staining of the skin by the test substance |
| 2 | 1 h | 1 | 0 | Yellow staining of the skin by the test substance |
| 3 | 1 h | 1 | 1 | Yellow staining of the skin by the test substance |
| 1 | 24 h | 1 | 0 | Yellow staining of the skin by the test substance |
| 2 | 24 h | 0 | 0 | Yellow staining of the skin by the test substance |
| 3 | 24 h | 1 | 1 | Yellow staining of the skin by the test substance |
| 1 | 48 h | 0 | 0 | |
| 2 | 48 h | 0 | 0 | |
| 3 | 48 h | 1 | 0 | Yellow staining of the skin by the test substance |
| 1 | 72 h | 0 | 0 | |
| 2 | 72 h | 0 | 0 | |
| 3 | 72 h | 0 | 0 | |
| 1 | 24 - 72 h | 0,33 | 0,00 | |
| 2 | 24 - 72 h | 0,00 | 0,00 | |
| 3 | 24 - 72 h | 0,67 | 0,33 | |
| mean | 24 - 72 h | 0,33 | 0,11 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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