Registration Dossier
Registration Dossier
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EC number: 229-662-0 | CAS number: 6642-31-5
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: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- 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-dimethyl-1,2,3,4-tetrahydropyrimidine-2,4-dione
- Details on test material:
- - Name of test material (as cited in study report):
1,3-Dimethyl-4-aminouracil, techn.
- Physical state: solid
- Lot/batch No.: 02064
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean: female: 2.45 kg; male: 2.54 kg
- Housing: 1 rabbit per cage
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- Concentration: 50 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% aqueous formulation (w/w)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: test patches were secured in position with a porous dressing: four layers of absorbent gauze and porous bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- other: 24 - 72hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Remarks on result:
- other: 24 - 72hours
Any other information on results incl. tables
Animal number |
1 |
2 |
3 |
Body weight |
2.54 |
2.41 |
2.49 |
Sex |
male |
female |
female |
Readings |
Animal |
Edema (score) |
Erythema (score) |
4 hours |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
24 hours |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
48 hours |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
72 hours |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
Evaluation of erythema and edema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to sever
4 = severe to very severe
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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