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Registration Dossier
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EC number: 278-113-1 | CAS number: 75199-08-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- EC Number:
- 278-113-1
- EC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Cas Number:
- 75199-08-5
- Molecular formula:
- C27H19CrN10O11S.2Na C27H19CrN10Na2O11S
- IUPAC Name:
- Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd.
- Housing: single cage (Type III)
- Diet (e.g. ad libitum): standard diet "ssniff K4" ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: 14 d minimum
- Sex: female
- Number of animals: 3
- Weight: 3.2 - 3.8 kg
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 45 - 65% r.h.
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (pasting with water)
NEGATIVE CONTROL
- Concentration (if solution): 100% water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Hansamed Wundpflaster hypoallergen
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h, 7 d after removal of test substance
No observation was performed after 14 d since no signs of irritation had occured before.
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not irritating
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not irritating
- Remarks on result:
- no indication of irritation
- Other effects:
- skin was stained red until 24 h after removal of test substance
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No erythema or edema were observed on rabbit skin after 24/48/72 h. The substance is not irritating to skin (score = 0.0). The substance is not classifiable as irritating to skin.
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