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Toxicological information

Skin irritation / corrosion

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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:
2001
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

Constituent 1
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

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