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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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 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
Reference substance name:
Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate
EC Number:
249-955-7
EC Name:
Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate
Cas Number:
29920-31-8
IUPAC Name:
dimethyl 5-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)isophthalate

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:
other: purified water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g/animal (mixed with 0.5 ml of purified water)
VEHICLE
- Amount applied: about 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

Skin reaction was assessed at approximately 1, 24, 48 and 72 hours, as well as 7 and 10 days after exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
with 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Individual animal data for animal #1, #2, #3 at time point 1h / 24h / 48h / 72 h / 7days / 10 days.

Edema score: 0/0/0/0/0/0, 0/0/0/0/0/0, 0/0/0/0/0/0
Erythema score: 1/1/1/1/0/0, 1/1/1/0/0/0, 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 was applied by topical semi-occlusive application of 0.5 g mixed with 0.5 ml of purified water to the intact 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 and 10 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 1.00, 0.67 and 0.00, respectively, and the mean oedema score was 0.00 for each of the three rabbits.

The application of test item to the skin resulted in very slight erythema. These effects were reversible and were no longer evident 7 days after treatment. The test item caused a yellow staining of the treated skin which persisted up to 7 days after treatment. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin.

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