Registration Dossier
Registration Dossier
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EC number: 278-770-4 | CAS number: 77804-81-0
Skin irritation / corrosion
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:
- 1 981
- 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
- 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
Constituent 1
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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