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Registration Dossier
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EC number: 211-951-8 | CAS number: 719-80-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted may12th, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Diphenylethoxyphospine
- IUPAC Name:
- Diphenylethoxyphospine
- Details on test material:
- - Name of test material (as cited in study report): Diphenylethoxyphosphin
- Physical state: liquid
- Analytical purity: no data
- Expiration date of the lot/batch: October 1982
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main
- Age at study initiation: no data
- Weight at study initiation: males: 3.23kg on average, female: 2.59kg
- Housing: single in steel cages (40 x 51cm)
- Diet (e.g. ad libitum): Ovator Solikanin 4mm, app. 130g per animal daily
- Water (e.g. ad libitum): app. 250ml per animal and day (VE water on weekdays, tap water on weekends)
- Acclimation period: app. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): app. 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): app. 0.5ml - Duration of treatment / exposure:
- 4h under occlusive conditions
- Observation period:
- 8 days (30-60min, 24h, 48h, 72h, and 8 days after exposure)
- Number of animals:
- 2males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4h
SCORING SYSTEM:
Erythema and edema are scored accoring to the following scale:
0: no effect
1: slight effect
2: well discernable effect
3: moderate to strong effect
4: strong to very strong effect
In addition, scaling will be noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: animals #1,2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: animal #3
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: animal #1
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- >= 0.3 - <= 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: animals #2,3
- Other effects:
- no effects observed during gross pathology
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- A single occlusive application of 0.5ml to intact rabbit skin for 4h elicited mild skin irritation.
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