Registration Dossier
Registration Dossier
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EC number: 221-070-0 | CAS number: 2997-92-4
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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-azobis[2-methylpropionamidine] dihydrochloride
- EC Number:
- 221-070-0
- EC Name:
- 2,2'-azobis[2-methylpropionamidine] dihydrochloride
- Cas Number:
- 2997-92-4
- Molecular formula:
- C8H18N6.2ClH
- IUPAC Name:
- 2,2'-diazene-1,2-diylbis(2-methylpropanimidamide) dihydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Vazo(R) 56 WSP
- Substance type: organic
- Physical state: solid
- Analytical purity: > 97 %
- Lot/batch No.: M0200
- Expiration date of the lot/batch: Not advised, but assumed to be stable for six months from date of receipt
- Storage condition of test material: stored at room temperature in the dark from date of receipt and at 4 °C in the dark from 10 December 1998
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.5 to 3.3 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Special Diet Services STANRAB (P) SQC pellet
- Water (e.g. ad libitum): Anglian Water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18- 19 °C
- Humidity (%): 28 to 43 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
moistened with 05. ml distilled water - Duration of treatment / exposure:
- four hours
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm * 25 mm
- Type of wrap if used: gauze pad, Elastoplast elastic adhesive
REMOVAL OF TEST SUBSTANCE
- Washing : warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of Vazo(R) 56 WSP to intact rabbit skin for four hours elicited no dermal irritation.
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