Registration Dossier
Registration Dossier
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EC number: 276-344-2 | CAS number: 72102-84-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is performed prior to the introduction of GLP and does not comply according to the current guidelines. The main objection is the fact that the test material was applied as a dry powder and not moistened sufficiently prior to application. As the substance is an insoluble organic pigment, this is considered acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
Test material
- Reference substance name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- EC Number:
- 276-344-2
- EC Name:
- 5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid
- Cas Number:
- 72102-84-2
- Molecular formula:
- C12H10N6O4
- IUPAC Name:
- 5-[(1E)-2-(6-methyl-2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)diazen-1-yl]-1,3-diazinane-2,4,6-trione
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: LV 86
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation: adult
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food -NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum water
- Acclimation period: a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6: 3 male, 3 female
- Details on study design:
- TEST SITE
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schropfschnapper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
REMOVAL OF TEST SUBSTANCE
The dressings were removed after a 24 hour application.
SCORING SYSTEM:
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of erythema and eschar formation and edema formation.
Calculation of the primary skin irritation Index:
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h & 4, 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h & 4, 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h & 4, 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h & 4, 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- other: primary irritation index
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- The test substance was found to cause no irritation when applied to intact and abraded rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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