Registration Dossier
Registration Dossier
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EC number: 442-640-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-12-03 to 2002-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 442-640-7
- EC Name:
- -
- Cas Number:
- 479541-17-8
- Molecular formula:
- Hill formula: C32H26CuFN9Na4O19S5
- IUPAC Name:
- Tetrasodium 2-(4-fluoro-6-(2-(2-sulfonatoethansulfonyl)ethyl amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(2-(2-hydroxy-5- sulfonatophenylazo)-4,5-dimethoxyphenylazo)-7-sulfonatonaphthalene-1-sulfonatocuprate(II)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Oliv F00-0149
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 3.1 - 3.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery (room number 051).
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Examinations took place after 30 - 60 minutes, 24, 48 and 72 hours after removal of the patches.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was carefully removed from the skin with warm tap water
- Time after start of exposure: following exposure period
SCORING SYSTEM: DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: <= 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- <= 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: <= 0 (related to all animals)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Reactive Olive F00-0149 is not irritation to the skin based on results from a rabbit skin irritation test according to OECD 404.
- Executive summary:
In a primary dermal irritation study, 3 rabbits weighing 3.1 -3.5 kg, were dermally exposed to 500 mg Reactive Olive F00-0149 in deionized water to 25 cm2 dorsal region skin. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days. Irritation was scored by the DRAIZE method.
In this study, Reactive Olive F00-0149 is not a dermal irritant.
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