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Toxicological information

Skin irritation / corrosion

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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:
1975
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

Constituent 1
Chemical structure
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'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
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

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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