Registration Dossier
Registration Dossier
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EC number: 940-436-7 | CAS number: 1354632-48-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- disodium 2-amino-4-acetamido-5-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 940-436-7
- Cas Number:
- 1354632-48-6
- Molecular formula:
- C16H18N4O10S3.xNa C16H16N4Na2O10S3 as disodium salt
- IUPAC Name:
- disodium 2-amino-4-acetamido-5-[(1E)-2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- see below
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, konventionelle Zucht
- Age at study initiation: -
- Weight at study initiation: 2 - 3.1 kg
- Housing: single
- Diet (e.g. ad libitum): Alleinfutter für Zuchtkaninchen ERKA Z 6000 (Futtermittelwerke Robert Koch oHG, Hamm/Westfalen), ad libitum
- Water (e.g. ad libitum): deionisiertes; gechlortes Wasser aus automatischen Tränken, ad libitum
- Acclimation period: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
In-life date: 12. to 15. October 1982
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- 0.15 mL to form a paste
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg on 2.5 cm x 2.5 cm gauze pads
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: Hansamed Wundpflaster and semi-occlusive wrapping
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
SCORING SYSTEM: OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Nach Einwirkung der angeteigten Substanz (4 Stunden Exposition) wurde aufgrund der Befunde der Erythem- und Oedembildung (1, 24, 48, 72 h) ein Reizindex von 0,8 ermittelt. Zusätzlich zu den in den Reizindex eingegangenen Symptomen waren die behandelten Hautstellen nach 30 Minuten großflächig gelb verfärbt Alle Reizerscheinungen waren bis auf eine leichte kaum wahrnehmbare Rötung bei einem Tier bereits innerhalb 48 Stunden nach Entfernung des Patch reversibel.
Unter den beschriebenen Versuchsbedingungen nach der OECO-Richtlinie zur Prüfung auf akute dermale Reizwirkung / Ätzwirkung ist die Substanz Remazol-Goldgelb RNL somit als leicht hautreizend zu bezeichnen.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was tested according to OECD 404 for skin irritation properties. The evaluation of the erythema and edema scores at the 24, 48, and 72 hour time points showed that the test item is not irritating to skin according to GHS and CLP evaluation schemes.
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