5-amino-1,3-dihydro-2H-benzimidazol-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-12 to 1989-09-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD and GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

EC Number:

202-401-8

EC Name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

Cas Number:

95-23-8

Molecular formula:

C7H7N3O

IUPAC Name:

5-amino-1,3-dihydro-2H-benzimidazol-2-one

Details on test material:

The test item contains about 38 % water. Reason is that this compound is manufacturer and further processed only as water wet substance.
It is not expected that the additional amount of water has an influence on the results.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3-3.4 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, Altromin GmbH, ad libitum and hay, 15 g daily
- Water (e.g. ad libitum): deionised, chlorinated water from automatic feeder, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

500 mg Aminolon TF in 0.2 ml 0.9% NaCl solution

Duration of treatment / exposure:

4 hrs, after application residual test substance was removed by rinsing with lukewarm tap water

Observation period:

Observations at 30-60 min, 24, 48 and 72 hrs after removal of test substance

Number of animals:

3

Details on study design:

Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of animal # 111, 112, 113 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no effects at any time

Results 2

Irritation parameter:

edema score

Basis:

other: mean of animal # 111, 112, 113 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: no effects at any time

Irritant / corrosive response data:

No signs of irritation/corrosion have been observed during the entire study period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Not irritating

Executive summary:

The test item was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg Aminolon TF mixed with 0.2 ml physiol. saline were applied to the shaved skin of New Zealand White rabbits. After 4 h exposure time the semiocclusive covering was removed and remaining substance was removed by rinsing with tap water. Mean scores (mean of 24, 48, 72h) were calculated for oedeme and erythema for each rabbit.

No signs of irritation have been observed during the entire study period. Based on these findings the test substance is neither skin irritating nor skin corrosing in this test.