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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 09 JUN 1981 to 12 JUN 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: FDA guideline (minor deviations from OECD guideline)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

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 material form:
solid: nanoform

Test animals

Species:
rabbit
Strain:
other: New Zealand

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
other: polyethylenglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted in 1,2 ml polyethylenglycol 400
Duration of treatment / exposure:
24 h
Observation period:
48 h after removal of patch with observation time points immediately after removal, 24 and 48 h later.
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact
Irritant / corrosive response data:
Intact skin:
Individual scores immediately after removal of patch were 0 in all animals.

Scarified skin:
2/6 animals showed an erythema score of 1 and 1/6 an edema score of 1 in the first reading (directly after unwrapping, i.e. 24 hours after start of exposure). 24 and 48 h after end of exposure no erythema or edema were detectable (score 0) in any animal.

Applicant's summary and conclusion

Conclusions:
The test material is not irritating to skin under these test conditions. Directly after removal of the patches with test material very slight erytema and edema scores were reported in few animals (score 1, in 2/6 or 1/6 animals respectively). These effects were reversible within 24 hours and no effects were seen at the 24 and 48 hour readung (i.e. 24 and 48 hours after patch removal; erythema and edema score = 0).

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