Registration Dossier
Registration Dossier
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EC number: 228-940-9 | CAS number: 6375-55-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 23 to October 23, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate
- EC Number:
- 228-940-9
- EC Name:
- Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate
- Cas Number:
- 6375-55-9
- Molecular formula:
- C32H24N8Na2O8S2
- IUPAC Name:
- NA
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bêgrolles en Mauges, France)
- Age at study initiation:
- Weight at study initiation: mean weight of 3 kg
- Housing: the rabbits were individually housed in polystyrene cages 0.35 x 0.55 x 0.32 M. Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): animals fed ad libitum with a certified pelleted Rabbit diet Ref. 112C (U.A.R., villemoisson sur Orge, France)
- Water: free access to tap water filtered with Millipore filters in water bottles. Routine bacteriological and chemical analysis of water were made, in order to detect major contaminants, by the Laboratoire Municipal, 76000 Rouen, France.
- Acclimation period: for at least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): the light/dark cycle was 12 hours per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm 2
- Type of wrap if used: hydrophilic gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test sample removed by swabbing with a gauze saturated with distilled water.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
at 24, 48 and 72 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no clinical signs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no clinical signs
- Irritant / corrosive response data:
- As the test sample stained the treated flank, it was impossible to detect slight erythema, but it was considered possible to evaluate well-defined
to severe erythema, had it been present.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- Non irritant
- Executive summary:
Method
The study was conducted in six New-Zeland white rabbits, according to the recommendations of the OECD Guideline 404.
Results
One hour after the application of the test sample, the staining of the skin of four animals (01, 03, 05, 06) presented observation of slight erythema. However, well-defined erythema, if present, would have been visible. On Day 2, the staining persisted in two animals (03, 06). On Day 3, no erythema and oedema was observed in any animal. The mean erythema score was 0, and the mean oedema score was 0.
Conclusion
Non irritant
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