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Toxicological information

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:
From 15 OCT 2003 to 18 OCT 2003
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:
2003
Report date:
2003

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:
2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
EC Number:
278-770-4
EC Name:
2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
Cas Number:
77804-81-0
Molecular formula:
C36H32N10O8
IUPAC Name:
2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2 to 3.5 kg
- Housing: Individually in suspended metal cages.
- Diet: certified rabbit diet (Code 5322, provided by International Product Supplies Limited, Wellingborough, UK); ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Remarks:
distilled
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:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 h

SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION
No erythema..................................................................................................................................0
Very slight erythema (barely perceptible).................................................................................1
Well-defined erythema.................................................................................................................2
Moderate to severe erythema......................................................................................................3
Severe erythema (beef redness) or eschar formation preventing grading of erythema...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 (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, #2, #3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
no signs of systemic toxicity, yellow staining at 1 and 24 h

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) No. 1272/2008
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 pasted with 0.5 ml of distilled 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 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 male rabbits (1 -hour).

This persisted up to the 24-hour reading. A very slight erythema was noted in all animals at the 1 -hour and the 24 -hour reading (maximum score observed: 1), but was no longer present at the 48 -hour reading. Therefore, the overall erythema score in all animals was 0.33 and the overall edema score was 0.