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Toxicological information

Skin irritation / corrosion

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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:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
particle size not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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