Registration Dossier
Registration Dossier
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EC number: 220-135-0 | CAS number: 2638-94-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 February 1999 - 19 July 1999
- 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)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no deviations that were considered to have affected the integrity or validity of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no deviations that were considered to have affected the integrity or validity of the study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- yes
- Remarks:
- no deviations that were considered to have affected the integrity or validity of the study
- GLP compliance:
- yes
- Remarks:
- expiry date of the test item is not indicated
Test material
- Reference substance name:
- 4,4'-azobis[4-cyanovaleric] acid
- EC Number:
- 220-135-0
- EC Name:
- 4,4'-azobis[4-cyanovaleric] acid
- Cas Number:
- 2638-94-0
- Molecular formula:
- C12H16N4O4
- IUPAC Name:
- 4,4'-azobis[4-cyanovaleric] acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature in the dark and at 4 °C in the dark
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: at least 13 weeks
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in stainless steel cages
- Diet: standard laboratory rabbit diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 19
- Humidity (%): 28 - 43
- 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 applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin was made on Day 1 (ie approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm
- Type of wrap: "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: washed with warm water (37°C)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 60 minutes, 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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