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Diss Factsheets

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
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
Perhydroimidazo[4,5-d]imidazole-2,5-dione
EC Number:
207-821-5
EC Name:
Perhydroimidazo[4,5-d]imidazole-2,5-dione
Cas Number:
496-46-8
Molecular formula:
C4H6N4O2
IUPAC Name:
perhydroimidazo[4,5-d]imidazole-2,5-dione
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch number: Zwischenprodukt aus Partie 692.
Date of manufacturing: 27 July 1998.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Test animals
Source: Boehringer Ingelheim Pharma KG.
Age: Young Adults.
Housing: Single Housing.
Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130g/animal/day)
Water: Tap water, ~250mL/day.
Acclimatisation Period: At least 1 week.

Environmental Conditions
Temperature (C): 20 - 24.
Humidity (%): 30-70.
Air changes (per hour): Not Reported.
Photoperiod (hrs dark/hrs light): 12/12.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
The test substance was moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physilogical conditions as possible).
Controls:
yes, concurrent negative control
Amount / concentration applied:
Amount applied was 0.5g of the unchanged solid test substance in a single dose to the intact untreated skin. Application site was the upper third of the back or flanks of the animals.
Duration of treatment / exposure:
Duration: 4 hours.
Date of application: 05 October 1998.
Observation period:
72 Hours
Number of animals:
3 (1 male, 2 females)
Details on study design:
At least 24 hours before the test, the fur was removed via clipping of the dorsal part of the trunk of each of the animals, those with healthy intact skin have been used.

The test substance was applied in a single dose and the test patch was secured in position with a semiocclusive dressing (test patch: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern; adhesive fleece: Fixomull(R) stretch, Beiersdorf AG). The test substance was then removed at the end of the exposure period with Lutrol (r) and Lutrol(R)/water (1:1) (Lutrol(R) E 400 = Polyethylenglycol DAB, BASF Aktiengesellschaft).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
0.7
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
0.7
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Exposure Period 4 hours
Reading Animal Erythema Edema
1 hr 1 1 0
2 1 0
3 0 0
24 hrs 1 1 0
2 0 0
3 1 0
48 hrs 1 1 0
2 0 0
3 1 0
72 hrs 1 0 0
2 0 0
3 0 0
Mean 1 0.7 0
2 0 0
3 0.7 0
Mean   0.4 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non-irritating to the skin.
Executive summary:

An in vivo study was conducted, according to OECD TG 404 (1999), to assess the acute dermal irritation or corrosion potential of the test substance. The study was conducted on three rabbits (New Zealand White). 0.5g of test substance was applied by a single topical application to the intact skin of the animal, for 4 hours under semi-occlusive dressing. The average score (24 -72 hours) for irritation was calculated to be 0.4 for erythema and 0.0 for oedema. The skin findings were reversible in all animals within 72 hours after the removal of the patches; as such the study was terminated after this period. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the skin and therefore is unclassified under Regulation 1272/2008.