Registration Dossier
Registration Dossier
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EC number: 281-719-9 | CAS number: 84029-45-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- EC Number:
- 281-719-9
- EC Name:
- Sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- Cas Number:
- 84029-45-8
- Molecular formula:
- C14H12N2O6S.Na
- IUPAC Name:
- sodium 4-(4-methyl-3-nitrobenzoylamino)benzenesulphonate
- Details on test material:
- purity: 89,9 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3,2 - 4,5 kg
- Housing: in single cages in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiat - Kaninchen ( ad libitum) and 15 g hay / day
- Water. deionized and chlorinated water from automatic suspensors ( ad libitum):
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg testitem suspend with 0.4 ml physiol. saline
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100 %
- Type of wrap if used: plaster and semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: slightly warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test result the substance has not to be classified as skin irrtant
- Executive summary:
The substance was tested for skin irritation according to OECD guideline 404. 500 mg suspended with 0.4 ml physiol. saline was applied to a clipped skin area of 2.5 cm x 2.5 cm, covered with with a semiocclusive bandage. After removal of the substance no irritation could be observed
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