Registration Dossier
Registration Dossier
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EC number: 458-880-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24. April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 458-880-0
- EC Name:
- -
- Cas Number:
- 85209-93-4
- Molecular formula:
- Hill formula: C29 H42 O4 P Li
- IUPAC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo- [d,g][1,3,2]dioxaphosphocin 6-oxide, lithium salt
- 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:
- Albino New Zealand White rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Weight at study initiation: 2.0 - 3.5 kg
- Age at study initiation: 12 - 20 weeeks
- Housing: individually in suspended metal cages, with environmental enrichment items
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322), BCM IPS Limited, London, UK
- Water (e.g. ad libitum): mains drinking water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 17 - 23
- Humidity (%): 30 to 70
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0,5 g test material
VEHICLE
- Amount applied: 0,5 ml distilled water
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution): - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hours - 4 hours; 24, 48 and 72 hours
- Number of animals:
- 3 (2 male, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: cotton gauze patch secured with surgical adhesive tape on the skin. To prevent animal interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to the Draize scheme (Draize, J.H. 1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 99
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: 100
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal: 101
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 99
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 100
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 101
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- no erythema, no edema observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant
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