Registration Dossier
Registration Dossier
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EC number: 230-847-3 | CAS number: 7336-20-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. However, test material purity was not listed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 4,4'-diaminostilbene-2,2'-disulphonate
- EC Number:
- 230-847-3
- EC Name:
- Disodium 4,4'-diaminostilbene-2,2'-disulphonate
- Cas Number:
- 7336-20-1
- Molecular formula:
- C14H14N2O6S2.2Na
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonate)
- Details on test material:
- - Name of test material (as cited in study report): 2,2'-Diaminostilbene-4,4'-disulfonsäure Di-Na-Salz
- Substance type: organic
- Physical state: powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: 91/099
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton Huntington; England
- Age at study initiation: no data
- Weight at study initiation: 3.0 - 3.7 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): stamdard, once per day 100-120g in the morning
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5 °C
- Humidity (%): 40-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance moistioned with water
VEHICLE
- Amount(s) applied (volume or weight with unit): no data - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lateral area of the trunk
- % coverage: 6*6 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hr after washing
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered not irritant to skin.
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