Registration Dossier
Registration Dossier
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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-07-09 to 1992-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on May 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- EC Number:
- 416-140-4
- EC Name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- Cas Number:
- 145650-60-8
- Molecular formula:
- C32H51 O3 P
- IUPAC Name:
- bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
- Details on test material:
- Physical properties: Solid, white
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss, Germany
- Weight at study initiation: 2250 to 2690g
- Housing: Individually in metal cages
- Diet: Standard rabbit pellet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left flank of each treated rabbit served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of the test item - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approx. 36 cm^2 on the flanks of the animals
- Type of wrap: the patches were loosely covered with an aluminum foil (approx. 36 cm^2) and held in place by an adhesive tape (Isoplast)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test substance caused minimal erythema reactions in one animal. The reactions were observed only one hour after removing the bandages and reversed back to normal at the 24 hour time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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