N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD and GLP 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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

EC Number:

247-820-7

EC Name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Cas Number:

26576-46-5

Molecular formula:

C11H11N3O3

IUPAC Name:

3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide

Details on test material:

- Name of test material (as cited in study report): Acetolon TTR

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Hoechst AG, Kastengrund, conventional breed
No of animals: 3
Identification of animals: Earmarks
Weight: 2.8 - 4.3 kg
Age: ca. 3 to 5 months
Caging in air conditioned rooms, single cages
Temperature: 20 +/- 3 °C
Relative humidity: 50 +/- 20 %
Light: 12 hrs daily
Diet: Altromin 2123 for rabbit, Altromin GmbH Lage/Lippe, ad libitum as well as hay (ca. 15 g daily)
Water: deionised, chlorinated water from automatic feeder, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

Amount of test substance applied: 500 mg Acetolon TTR
Amount of vehicle: 0,8 ml of 0.9% NaCl solution

Duration of treatment / exposure:

Duration of exposure: 4 hrs, after 4 hrs removal of residual test substance with lukewarm tap water

Observation period:

Observations at 30-60 min and 24, 48 and 72 hrs after patch removal.

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 # 98, 99, 100 each

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Reversibility:

other: no signs of irritation or corrosion (all scores 0, no other effects) during the entire observation period

Results 2

Irritation parameter:

edema score

Basis:

other: mean of animal # 98, 99, 100 each

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Reversibility:

other: no signs of irritation or corrosion (all scores 0, no other effects) during the entire observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.

Executive summary:

Acetolon TTR was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 500 mg test substance mixed with 0.8 ml physiol. saline were applied to the shaved skin of 3 New Zealand White rabbits. After 4 h exposure time the semiocclusive patch was removed. Residual test substance was removed with lukewarm tap water. Animals were examined for signs of skin irritation and/or corrosion at 30-60 min, 24, 48, and 72 h after patch removal. Mean scores (mean of 24, 48, 72h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.