2-ethyl-4-methylimidazole

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

2-ethyl-4-methylimidazole

EC Number:

213-234-5

EC Name:

2-ethyl-4-methylimidazole

Cas Number:

931-36-2

Molecular formula:

C6H10N2

IUPAC Name:

2-ethyl-4-methyl-1H-imidazole

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 or test system 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

Results

Results 1

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)

Results 2

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)

Results 3

Irritation parameter:

edema score

Remarks:

4 h exposure

Basis:

mean

Time point:

other: 4 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 4

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

Results 5

Irritation parameter:

edema score

Remarks:

4 h exposure

Basis:

mean

Time point:

other: 8 d

Score:

1.5

Max. score:

4

Reversibility:

not reversible

Results 6

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

Results 7

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