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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404), performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
EC Number:
257-515-0
EC Name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide
Cas Number:
51920-12-8
Molecular formula:
C27H24N6O6S
IUPAC Name:
3-hydroxy-4-{[2-methoxy-5-methyl-4-(methylsulfamoyl)phenyl]diazenyl}-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-naphthamide
Test material form:
solid: nanoform, no surface treatment

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kisslegg, Germany
- 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. 85/05; 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 moistened with appr. 0.5 mL purified water

VEHICLE
- Amount applied: 0.5 mL/animal
Duration of treatment / exposure:
4 h
Observation period:
14 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no effect
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At the first observation, 1 hour after the application, erythema was not assessable due to marked red staining by the test item. This staining persisted as a light staining until the end of the 14 day observation period. No irritant or corrosive effects were noted on the treated skin of any animal at any of the measuring intervals (all scores for erythema or edema = 0) and no clinical signs were observed.
Other effects:
no other effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not reveal any 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 was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. At the first observation, 1 hour after the application, erythema was not assessable due to marked red staining by the test item. This staining persisted as a light staining until the end of the 14 day observation period. No irritant or corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

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