Registration Dossier
Registration Dossier
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EC number: 259-470-2 | CAS number: 55067-15-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-02-06 to 1990-02-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)
- EC Number:
- 259-470-2
- EC Name:
- 2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)
- Cas Number:
- 55067-15-7
- Molecular formula:
- C19 H13 N7 O5 S2 . C6 H15 N O3
- IUPAC Name:
- 2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: Op. 604/89
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2340 to 2670 g
- Housing: individually
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: Destilled water was used to moisten a gauze patch. - Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm2
SCORING SYSTEM:
Skin reactions were evaluated according to the OECD scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- A substance related orange-staining was observed in all animals until 24 hours after removal of the patch.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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