Registration Dossier
Registration Dossier
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EC number: 248-421-0 | CAS number: 27344-41-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards but no data how the test substance was dissolved.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- EC Number:
- 248-421-0
- EC Name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- Cas Number:
- 27344-41-8
- Molecular formula:
- C28H22O6S2.2Na
- IUPAC Name:
- disodium 2,2'-(biphenyl-4,4'-diyldiethene-2,1-diyl)dibenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): FAT 65029/B
- Analytical purity: 90% ± 3%
- Impurities: Sodium choride and water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.6 to 2 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one side shaved, the other abraded
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): For treatment gauze patches of 2.5 x 2.5 cm soaked with the test substance were applied to the prepared abraded and non abraded skin.
- Concentration (if solution): no data - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: flank, 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 hours
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: within 72 hours
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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