Registration Dossier
Registration Dossier
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EC number: 205-117-2 | CAS number: 133-66-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented report which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For SIAM 21
- Author:
- OECD
- Year:
- 2 007
- Bibliographic source:
- OECD SIDS
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- In deviation of modern guidelines occlusive patches were used in this study, representing exaggerated exposure conditions.
- Principles of method if other than guideline:
- The procedure used is based, but not in every part identical with the proposed guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study". Federal Register, Vol 43 No. 163, August 22, 1978.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- EC Number:
- 240-245-2
- EC Name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- Cas Number:
- 16090-02-1
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}
- Details on test material:
- - Name of test material (as cited in study report): FAT 65'023/L
- Physical state: powder
- Analytical purity: active substance content 83%,
- Lot/batch No.: EN 20
- Stability under test conditions: not determined
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- adraded skin
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Erythema score after 24, 48 and 72 h (animal1/2/3/4/5/6)
| Exposure time | 24 h | 48 h | 72 h | |
| intact skin | 2/2/2/2/1/1 | 2/2/2/2/1/1 | 1/2/1/1/0/0 | |
| abraded skin | 2/1/0/2/1/1 | 1/1/0/2/1/1 | 1/0/0/0/0/0 |
Edema score after 24, 48 and 72 h (animal1/2/3/4/5/6)
| Exposure time | 24 h | 48 h | 72 h | |
| intact skin | 1/2/1/0/0/0 | 1/1/1/0/0/0 | 0/1/0/0/0/0 | |
| abraded skin | 1/1/0/1/0/0 | 1/0/0/0/0/0 | 1/0/0/0/0/0 |
All effects were fully reversible within 7 days (all scores: 0.0). There was no staining of the treated skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritant to skin.
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