Registration Dossier
Registration Dossier
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EC number: 248-655-3 | CAS number: 27776-21-2
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Number of animals: 6; Exposure time: 24 h; Intact and abraded skin was exposed
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-Azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride
- Cas Number:
- 27776-21-2
- IUPAC Name:
- 2,2'-Azobis[2-(2-imidazolin-2-yl)propane] dihydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- particle size not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The rabbits were individually house in metal cages,
Room temperature: 19 °C
Relative humidity: 30-70 %
Air exchange: 19/h
Aritificial light: 12h in each 24 hour period
Test system
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0,5 g amount of 2,2’-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride, was applied under a 2.5 cm square gauze pad moist with 0,5mL distiiled water
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Erythema and Eschar Formation
No erythema...................................................................................................................... 0
Very slight erythema (barely perceptible) ............................................................. ........... 1
Well defined erythema .................................................................................................... ...2
Moderate to severe erythema ...................................................................................... ...... 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema..... ... 4
Maximum possible: 4
Oedema Formation No oedema ............................................................................................ 0
Very slight oedema (barely perceptible) ...................................................... ...... . 1
Slight oedema (edges of area well defined by definite raising) .............................. ............ 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ......... ..... 4
Maximum possible: 4
Applicant's summary and conclusion
- Interpretation of results:
- other: Based on "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics", published by the Association of Food and Drug Officials of the United States, 1959, p. 46.
- Conclusions:
- 2,2’-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride is considered to be non - irritant to rabbit skin
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