Registration Dossier
Registration Dossier
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EC number: 309-913-1 | CAS number: 101357-16-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD 404. No GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data recorded on body weights, the exposure period was 24 hours instead of 4 h, the applied amount of the test substance was lower than that recommended in the guidelines)
- Principles of method if other than guideline:
- Modification of the method described by Draize (1944).
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
- EC Number:
- 309-913-1
- EC Name:
- Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
- Cas Number:
- 101357-16-8
- Molecular formula:
- Not applicable. Multiconstituent substance.
- IUPAC Name:
- (2Z,7Z)-5-phenyl-2,7-bis(phenylimino)-2,7-dihydro-5λ⁵-phenazin-5-ylium (7Z)-N2,N3,5-triphenyl-7-(phenylimino)-5,7-dihydrophenazine-2,3-diamine N2,N3,5,7-tetraphenyl-5,7,12,14-tetrahydro-5,7,12,14-tetraazapentacene-2,3-diamine chloride
Constituent 1
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approx. 3 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A solution of 0.4 g/ml of the test substance in distilled water was prepared. 0.5 ml of this solution were applied to the animals. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: sterile gauze and wax paper.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beefy redness) to eschar formation 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as skin irritating.
- Executive summary:
The test item was applied only once to the shaved skin of three animals. The exposure lasted 24 hours. Observations of the treated skin were performed at 24, 48 and 72 hours after the end of the exposure. Based on the available results, the test substance is not classified as skin irritating.
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