Registration Dossier
Registration Dossier
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EC number: 286-344-4 | CAS number: 85209-91-2
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:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
- EC Number:
- 286-344-4
- EC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
- Cas Number:
- 85209-91-2
- Molecular formula:
- C29H43O4P.Na
- IUPAC Name:
- sodium 5,7,13,15-tetra-tert-butyl-10-oxo-9,11-dioxa-10λ⁵-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3,5,7,13,15-hexaen-10-olate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Adult albino rabbits, Hra:(NZW)SPF
- Source:Hazleton Research Products, Inc., Denver PA
- Weight at study initiation: 2032 - 2116 g
- Housing: individually in screen-bottom cages,
- husbandry and housing: addording to "Guide for the Care and Use of Laboratory Animals" (NIH Publication No. 86-23 (revised 1985)).
- Diet (e.g. ad libitum): measured, High Fiber Rabbit Chow® 5326, Purina Mills, Inc.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Temperature (°C): 18.9-23.3
- Humidity (%):48 to 55
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0,5 g test material (moistened with 0,9% saline)
VEHICLE
- Concentration (if solution): 0,9% saline - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes = 4 hours; 24, 48, and 72 hours after patch removal
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: gauze patch secured with paper tape, loosely overwrapped with Saran Wrap® and secured with Elastoplast® tape to provide a
semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 4 h
SCORING SYSTEM:according to the Draize technique (Draize, J.H. 1975)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over 6 animals
- 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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