N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 28 JUN 2006 to 13 JUL 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: 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)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide

EC Number:

279-914-9

EC Name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide

Cas Number:

82199-12-0

Molecular formula:

C18H17N5O4

IUPAC Name:

2-[(1E)-2-(2-methoxyphenyl)diazen-1-yl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)butanamide

Test material form:

solid: bulk

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: 11-12 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 24/06; provided by Provimi Kliba AG, CH-4303 Kaiseraugst); ad libitum
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g/animal
VEHICLE
- Amount applied: 0.5 mL/animal

Duration of treatment / exposure:

4 h

Observation period:

10 days

Number of animals:

3 (1 male, 2 females)

Details on study design:

TEST SITE
- Area of exposure: 4 cm x 4 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
Grading of Skin Reactions according to COMMISSION DIRECTIVE 2004/73/EC, APRIL 29, 2004
ERYTHEMA AND ESCHAR FORMATION
No erythema................................................................................................0
Very slight erythema..................................................................................1
Well-defined erythema...............................................................................2
Moderate to severe erythema...................................................................3
Severe erythema (beef redness) or eschar formation
(injuries in depth preventing erythema) reading...................................4

OEDEMA FORMATION
No oedema....................................................................................................0
Very slight oedema (barely perceptible)...................................................1
Slight oedema (edges of area well-defined by definite raising)............2
Moderate oedema (edges raised approximately 1 mm).........................3
Severe oedema (raised more than 1 mm and extending
beyond the area of exposure)....................................................................4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

individual animal data 1h / 24h / 48h / 72h / 7 days / 10 days after removal of patch for animal #1-#3 :

erythema: 0/0/0/0/0/0, 1/0/0/0/0/0, 1/0/0/0/0/0

edema: 0/0/0/0/0/0, 0/0/0/0/0/0, 0/0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not reveal any remarkable irritation potential on the skin of rabbits, tested in this study according to OECD test guideline no. 404 and GLP conditions.

Executive summary:

The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.The test item (0.5 g moistened with 0.5 ml purified water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 and 10 days after removal of the test item.

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. A light yellow staining was produced by the test item on the treated skin of the three rabbits. This persisted up to the 48-hour reading or up to day 7. A very slight erythema was noted in two animals at the 1-hour reading but was no longer present on the following day. Therefore, all scores are 0.