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EC number: 609-336-8 | CAS number: 371756-75-1
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: Acceptable, well documented study report which meets basic scientific principles
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)
- Deviations:
- yes
- Remarks:
- occlusive, 24 hour treatment
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 237-600-9
- EC Name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 13863-31-5
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Details on test material:
- - Analytical purity: > 80%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2.0 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: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours after initiation of treatment
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: impermeable material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
Skin Irritation Score:
|
|
intact skin |
abraded skin |
||
animal no. / sex |
time after application |
erythema |
edema |
erythema |
edema |
1/m |
24 h |
0 |
0 |
2 |
0 |
2/m |
1 |
0 |
2 |
2 |
|
3/m |
0 |
0 |
1 |
1 |
|
4/f |
1 |
0 |
2 |
1 |
|
5/f |
1 |
1 |
2 |
1 |
|
6/f |
1 |
1 |
2 |
2 |
|
1/m |
72 h |
0 |
0 |
0 |
0 |
2/m |
0 |
0 |
1 |
1 |
|
3/m |
0 |
0 |
1 |
0 |
|
4/f |
0 |
0 |
1 |
0 |
|
5/f |
0 |
0 |
0 |
0 |
|
6/f |
0 |
0 |
1 |
0 |
|
1/m |
mean 24 - 72 h |
0 |
0 |
1 |
0 |
2/m |
0.5 |
0 |
1.5 |
1.5 |
|
3/m |
0 |
0 |
1 |
0.5 |
|
4/f |
0.5 |
0 |
1.5 |
0.5 |
|
5/f |
0.5 |
0.5 |
1 |
0.5 |
|
6/f |
0.5 |
0.5 |
1.5 |
1 |
|
|
mean 24 - 72 h |
0.3 |
0.2 |
1.3 |
0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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