Registration Dossier
Registration Dossier
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EC number: 231-501-4 | CAS number: 7597-60-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, § 1500.41 (skin), p. 27019, September 27, 1973
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 6-amino-5-formamido-1,3-dimethyluracil
- EC Number:
- 231-501-4
- EC Name:
- 6-amino-5-formamido-1,3-dimethyluracil
- Cas Number:
- 7597-60-6
- Molecular formula:
- C7H10N4O3
- IUPAC Name:
- N-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide
- Details on test material:
- - Name of test material (as cited in study report): 1,3-dimethyl-4-amino-5-formylaminouracil
- Substance No. 80/205
- Physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler GmbH, Offenbach
- Weight at study initiation: mean 2.84 kg (males), 2.88 kg (females)
- Housing: sngle hoausing in steinless steel wire mesh cages (floor area 40 x 51 cm)
- Diet (e.g. ad libitum): OVATOR SOLIKANIN 4 MM ; Mukator-Werke, Duesseldorf (ca. 130 g daily/animal)
- Water (e.g. ad libitum): VE-water (mondays-fridays), tap water (weekends); ca. 25 ml daily/animal
- Acclimation period: at least 8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact
- Vehicle:
- water
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- Concentration: 50 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: upper third of backs
- Type of wrap if used: cotton lint (2.5x2.5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
acc. to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- The test substance led to very slight erythema at the intact skin sites in 2/6 animals at the 24-h reading. Thereafter no other findings were recorded. At the abraded skin sites very slight to severe erythema was seen in all 6 animals and very slight to slight edema was seen in 2/6 animals at the 24-h reading. At the 72-h reading there was still very slight erythema in 4/6 animals but edema showed to be reversible within that time. 8 days after skin treatment desquamation was seen in 4/6 animals.
Any other information on results incl. tables
Results:
Animal 1: female, 1.91 kg
Animal 2: female, 3.06 kg
Animal 3: male, 2.68 kg
Animal 4: male, 2.96 kg
Animal 5: male, 2.68 kg
Animal 6: male, 3.03 kg
Scoring:
| Readings | Animal | Erythema | Edema | Additional findings |
| 24 h | 1 | 1 | 0 | |
| 2 | 1 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| 48 h | 1 | 1 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| 8d | 1 | 0 | 0 | |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| 4 | 0 | 0 | ||
| 5 | 0 | 0 | ||
| 6 | 0 | 0 | ||
| Mean 24 - 72 h | 1 | 0.7 | 0.0 | |
| 2 | 0.3 | 0.0 | ||
| 3 | 0.0 | 0.0 | ||
| 4 | 0.0 | 0.0 | ||
| 5 | 0.0 | 0.0 | ||
| 6 | 0.0 | 0.0 | ||
| mean | 0.2 | 0.0 | ||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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