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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Three test groups of animals were treated for 4 hour, 1 hour an 3 minutes respectively using occlusive conditions. An application site of 2x2 cm was covered with the liquid test substance. After the application time (4 h) the skin was washed with Lutrol or water/Lutrol mixture (1:1). The animals were observed for 8 days and skin changes were recorded. The report describes findings after 4, 24 and 48 hours and at the end of the observation period (8 days).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Dimethylimidazol
- Substance no.: 79/636

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach)
- Weight at study initiation: 4hr test: 3.4 kg, 1hr test: 3.3 kg, 3 minut test: 2.9 kg
- Diet: Ssniff K, standard diet for rabbits and guinea pigs (Firma INTERMAST GMBH, Soest), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 80% aqueous preparation
Duration of treatment / exposure:
4 hours, 1 hour and, 3 minutes
Observation period:
8 days
Number of animals:
4 hour test: 3 male and 3 female
1 hour test: 1 male and 1 female
3 minute test: 1 male and 1 female
Details on study design:
Approximately 15-24 hours before treatment, the backs and sides of the animals were shaved with an electric clipper. On test day 1, a skin area of approx 2 x 2 cm was exposed for 4 hours, 1 hour and 3 minutes using a patch holding the chemical. During exposure the test areas were covered with inert foil and fixed with adhesive bandage. In the 3 minute exposure test the test patches were held manually against the animals. After exposure the treated skin was washed with Lutrol or a water/Lutrol mixture (1:1) and dried with cellulose towels.

TEST SITE
- Area of exposure: 2 x 2 cm
- Type of wrap: rubberised linnencloth, fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (50% or 100%) and dried with cellulose
- Time after start of exposure: up to 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 4 hour
Score:
0 - 4
Max. score:
4
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
24 h
Score:
0 - 2
Max. score:
4
Remarks on result:
other: slight superficial necrosis observed in one animal
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
48 h
Score:
1 - 4
Max. score:
4
Remarks on result:
other: slight/patchy superficial necrosis observed in three animals
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 8 days
Score:
0 - 4
Max. score:
4
Remarks on result:
other: patchy/parchment-like superficial necrosis and scale formation observed in five animals
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 4, 24, 48 hour, 8 days
Score:
0 - 2
Max. score:
4
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 1 hour
Score:
2 - 3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 24 hour
Score:
1 - 3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 48 hour
Score:
1 - 3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 8 days
Score:
1 - 2
Max. score:
4
Remarks on result:
other: patchy superficial necrosis and scale formation
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 24 hour
Score:
0 - 2
Max. score:
4
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 48 hour, 8 days
Score:
0 - 1
Max. score:
4
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Time point:
other: 3 min
Score:
1 - 2
Max. score:
4
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Time point:
other: 24, 48 hour, 8 days
Score:
0
Max. score:
4
Remarks on result:
other: scale formation in one animal on day 8
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
mean
Time point:
other: 3 min, 24, 48 hour, 8 days
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information