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EC number: 255-527-0 | CAS number: 41741-86-0
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-10-25 to 1978-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, § 1500.41, 1973 (Draize test)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- EC Number:
- 255-527-0
- EC Name:
- Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)
- Cas Number:
- 41741-86-0
- Molecular formula:
- C34 H24 Cr N8 O6 .Na
- IUPAC Name:
- Sodium;chromium(3+);2-[(3-methyl-5-oxido-1-phenylpyrazol-4-yl)diazenyl]benzoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: The rabbits are kept in individual cages measuring 540 x 360 x 315 mm or in restraining devices which allow the back of the animal to be treated. The animal house is ventilated.
- Diet: 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS).
- Water: Water is given automatically and ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55 ± 10
- Air changes (per hr): 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 g per zone/per animal (made into a paste immediately, using 0.65 mL of neutralized, sterilized olive oil)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
The six rabbits are clipped with a fine toothed electric clipper (AESCULAP - Type V 42 947) to bare a skin surface of 14 cm X 14 cm (The cutting height = 1/20e mm); thus a precise cut can be achieved without irritating the skin mechanically. The animals are left to rest for 24 hours and then only those with perfectly healthy skin are chosen for the test. The right flank is scarified with a sterile scalpel blade, making three parallel superficial incisions 2 cm long and 0.5 cm apart. The incisions are epidermal and do not damage the dermis (should bleeding occur, a fresh animal is utilized).
- Area of exposure: The compound to be tested is applied to the rabbit skin; using the right, previously scarified flank and the left intact one, at a rate of 0.5 mL per area and animal in the case of a viscous compound and at 0.5 g per area and animal when dealing with a powdery or pasty material (solid material -powder- is applied in paste form).
- % coverage: These treated areas are subsequently covered with a 2 cm square gauze pad consisting of sterile, hydrophilic gauze of four layers. The material to be tested and the gauze pads are kept in contact with the skin by a patch* (NEODERMOTEST ROC) consisting of a central, circular disc of 22 mm diameters with a surrounding adhesive, hypoallergenic, perforated plaster 10 mm wide.
* Occlusive patches are used to keep the product in contact with the skin, since they increase the hydration of the skin and the permeability of the stratum corneum.
- Type of wrap: An adhesive tape 6 cm wide is wound around the animal to complete the fixing of the patches. Care is taken so that the respiratory and abdominal movements of the animal are not restricted.
SCORING SYSTEM:
Readings are made of both the scarified and non-scarified zones, following the scale of scores proposed by the "Journal Officiel":
- Erythematous (and scar) lesions
No erythema = 0
Very slight erythema (barely perceptible) = 1
Well defined erythema = 2
Moderate to severe erythema = 3
Severe erythema, crimson red, with slight eschar formation (injuries in depth) = 4
- Oedematous lesions
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well defined by definite raising) = 2
Moderate oedema (area raised approximately 1 mm) = 3
Severe oedema (raised more than 1 mm and extending beyond area of application) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 25, 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 25, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 25, 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: slight desquamation at the end of the study period. (intact skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 25, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 25, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: slight desquamation at the end of the study period. (intact skin)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 25, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 25, 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 25, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 25, 72 hours
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 25, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- - Slight desquamation of skin (intact and scarified) observed at 3 rabbits during erythema assessment.
- No edema was observed in any of the tested animals.
- Slight irritations on skin reversible within 7 days
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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