Registration Dossier
Registration Dossier
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EC number: 277-873-1 | CAS number: 74441-05-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 08 APR 1980 to 11 APR 1980
- Reliability:
- 2 (reliable with restrictions)
- 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:
- 1 980
- Report date:
- 1980
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:
- N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide
- EC Number:
- 277-873-1
- EC Name:
- N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide
- Cas Number:
- 74441-05-7
- Molecular formula:
- C25H21N7O5
- IUPAC Name:
- N-(4-carbamoylphenyl)-4-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)benzamide
- Test material form:
- solid: nanoform
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMAin-house breed colony
- Weight at study initiation: 1.8 -2.4 kg
- Housing: single
- Diet: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted in 1.5 ml 0.9 % physiol. saline - 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
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: erythema and edema scores (0-4)
Skin was evaluated immediately, 24 h and 48 h after after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #4, #6 each
- Time point:
- other: mean of 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24 and 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the shortened observation period of 48 h
- Remarks on result:
- other: clipped intact / Expected to be reversible in the course of a prolonged observation period
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean of 24 and 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- 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:
- individual animal data immediately / 24 h / 48 h after removal of patch for animal #1-#6 :
erythema: 0/0/0, 0/0/0, 1/1/1,
1/0/0, 0/1/0, 0/0/0
edema: 1/0/0, 0/0/0, 1/0/0,
0/0/0, 0/0/0, 1/0/0
Effects from scarified skin were a little stronger, but in the same range.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not reveal any remarkable irritation potential onto the skin of rabbits under these test conditions (FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)). 500 mg of substance were applied to the skin of six animals and skin reactions were noted for 48 h after end of exposure (exposure lasted for 24 h).Only slight effects could be observed (erythema score 1, edema score 1), 1/6 animals had still an erythema score of 1 at the end of the observation time. It can be concluded that a longer observation period would have resulted in a complete reversibility.
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