Registration Dossier
Registration Dossier
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EC number: 219-169-9 | CAS number: 2379-81-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 31, 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study has been conducted according to procedures similar to the accepted guidelines but the content of the active ingredient in the substance composition is low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
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
Test material
- Reference substance name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- EC Number:
- 219-169-9
- EC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Cas Number:
- 2379-81-9
- Molecular formula:
- C42H23N3O6
- IUPAC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Porton strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.72 - 3.37 kg
- Housing: rabbits caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week prior treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 10 hours daily from 08.00 - 18.00 hours
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 ml
- Concentration (if solution): 50 % w/v - Duration of treatment / exposure:
- 24 hours
- Observation period:
- after 24 and 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm per side
- Type of wrap if used: gauze pad
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
24 and 72 hours
SCORING SYSTEM: according to Draize et al. 3. Pharmac. Exp. Ther. 8_2_ 377 1944.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 11, 13, 15, 16
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 12
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 11, 15
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: 12, 13, 14, 16
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin irritant
- Executive summary:
The substance was tested according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965) on 3 male and 3 female rabbits.
Under test condition the substance resulted to be not irritant to skin.
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