Registration Dossier
Registration Dossier
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EC number: 616-020-3 | CAS number: 7381-13-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2007 - May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- EC Number:
- 616-020-3
- Cas Number:
- 7381-13-7
- Molecular formula:
- C20H24N2O4
- IUPAC Name:
- 1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one
- Details on test material:
- none
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Weight during the test: 2.23 kg .- 2.92 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Acclimation period: 5-day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19°C and 22°C
- Humidity (%): between 40% and 70%
- conventional air conditioned
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose of 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were appreciated I hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after the treatment the study is terminated - Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: on an undamaged skin area of one flank of each animal
- Type of wrap if used: strip of surgieal adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water
- Time after start of exposure:
SCORING SYSTEM:
Erythema and Eschar formation:
0 ...... No erythema
1 ...... Very slight erythema (barely perceptible)
2 ...... Well defined erythema
3 ...... Moderate to severe erythema
4 ... ... Severe erythema (beef redness) with eschars formation preventing grading of erythema
Oedema:
0 ....... No oedema
1 ....... Very slight oedema (barely perceptible)
2 ....... Slight oedema (contour clearly defined)
3 ....... Moderate oedema (raised approx. 1 mm)
4 ...... Severe oedema (raised more than 1mm, and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema and eschar
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 1,24,48,72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No cutaneous reactions
- Irritation parameter:
- edema score
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 1,24,48,72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No cutaneous reactions
- Irritant / corrosive response data:
- - Raw data for each individual animal at each observation time up to removal of each animal from the test: data are given in above block of fields
'Irritation / corrosion results'. - Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not to be classified
- Executive summary:
The test item was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing
during 4 hours on an undamaged skin area of three New Zealand rabbits.
No cutaneous reactions (el)'thema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).
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