Registration Dossier
Registration Dossier
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EC number: 201-325-2 | CAS number: 81-11-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- 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:
- 1 993
- Report date:
- 1993
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:
- 4,4'-diaminostilbene-2,2'-disulphonic acid
- EC Number:
- 201-325-2
- EC Name:
- 4,4'-diaminostilbene-2,2'-disulphonic acid
- Cas Number:
- 81-11-8
- Molecular formula:
- C14H14N2O6S2
- IUPAC Name:
- 2,2'-ethene-1,2-diylbis(5-aminobenzenesulfonic acid)
- Details on test material:
- - Name of test material (as cited in study report): 2,2'-Diaminostilbene-4,4'-disulfonsäure
- 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.: P 2081 VM
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- 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: 3.4 - 4kg
- 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:
- 7 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
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- other: no details available
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details available
- Irritation parameter:
- erythema score
- Basis:
- other: no details available
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no further details on erythema score
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr after washing
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified for skin irrittaion according to CLP criteria
- Conclusions:
- not irritant to skin.
- Executive summary:
The skin irritation potential of the test substance was evaluated in an vivo experimenatl study according to OECD Guideline 404. Based on the results the test substance is considered not irritant to skin.
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