Registration Dossier
Registration Dossier
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EC number: 241-734-3 | CAS number: 17741-63-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)
- EC Number:
- 241-734-3
- EC Name:
- N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)
- Cas Number:
- 17741-63-8
- Molecular formula:
- C40H34N6O8
- IUPAC Name:
- N,N'-(6,13-diacetamido-2,9-diethoxy[1,4]benzoxazino[2,3-b]phenoxazine-3,10-diyl)dibenzamide
- Test material form:
- solid: nanoform
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 3 - 4 months
- Weight at study initiation: male 2.20 kg and female 2.32 kg
- Housing: single
- Diet: commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: sterile filtered water was available at all times
- Acclimation period: one week prior to the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): artificial light for 10 hours daily from 8:00 - 18:00 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: left shaved; right shaved+abraded
- Vehicle:
- other: 50% solution of polyethylene glycol and water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 15 mL
- Concentration (if solution): 50% solution of polyethylene glycol and water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males, 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2 test sites of 2.5 cm2
- % coverage: 10%
- Type of wrap if used: Gauze pad covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban"-self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.83
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact and abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact and abraded skin
- Irritant / corrosive response data:
- A very slight to slight oedema was present in 5/6 rabbits 24 hours after application of the compound. All sites were clear by 72 hours.
There was no significant difference between intact and abraded sites.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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