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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test: Animals were treated for 4 hour using occlusive conditions. An application site of 2x2 cm was covered with the test substance. After the application time (4 h) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 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): 2-Äthyl-4(5)-methylimidazol; EMI 2,4

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.GAUKLER (6050 Offenbach)
- Weight at study initiation: male ca. 2.80 kg, female ca. 2.65 kg
- Diet: Sniff 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:
80 % aquatic solution (0.5 g)
Duration of treatment / exposure:
4 hours and 1 hour
Observation period:
8 days
Number of animals:
2 per exposure duration
Details on study design:
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 towels
- Time after start of exposure: 4 h and 1 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 4, 24, 48 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (soft movable, patchy)
Irritation parameter:
erythema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 8 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (parchment-like)
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 h exposure
Basis:
mean
Time point:
other: 8 d
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 4, 24, 48 h and 8 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Time point:
other: 4, 24, 48 h and 8 d
Score:
0
Max. score:
4
Irritant / corrosive response data:
Moderate to severe erythema and edema was observed after an exposure of 4 hours. No signs of erythema nor edema were observed after an exposure of 1 hour.
Other effects:
Clinical symptoms were not observed

Applicant's summary and conclusion

Interpretation of results:
other: irritating