Registration Dossier
Registration Dossier
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EC number: 241-769-4 | CAS number: 17791-81-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-01-04 and 1991-08-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study, according to OECD Guideline 404 and Directive 84/449 EEC, B.4.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
- EC Number:
- 241-769-4
- EC Name:
- Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]
- Cas Number:
- 17791-81-0
- Molecular formula:
- C60 H46 N16 Na6 O22 S6
- IUPAC Name:
- 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-(4-morpholinyl)-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(2-phenyldiazenyl)-2,7-naphthalenedisulfonic acid] hexasodium salt
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstraße 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.9 kg, female 3.1 kg
- Housing: individually in stainless steel cages (size: 35.5 x 55.5 x 45 cm) equipped with an automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341, Batch 61/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Water Community tap water from Itingen, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males
1 female - Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the OECD scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h/48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h/ 48 h / 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h/48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h/ 48 h/ 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred. In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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