Registration Dossier
Registration Dossier
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EC number: 224-481-3 | CAS number: 4378-61-4
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
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: Code of Federal Regulations, Title 16, Section 1500.41
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- pre-guideline study
Test material
- Reference substance name:
- 4,10-dibromodibenzo[def,mno]chrysene-6,12-dione
- EC Number:
- 224-481-3
- EC Name:
- 4,10-dibromodibenzo[def,mno]chrysene-6,12-dione
- Cas Number:
- 4378-61-4
- Molecular formula:
- C22H8Br2O2
- IUPAC Name:
- 4,10-dibromonaphtho[7,8,1,2,3-nopqr]tetraphene-6,12-dione
- 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: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact or shaved abraded with a scarifying instrument
- Vehicle:
- other: type vehicle used not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test item (The amount used is not explicitely specified in the report, but according to the guideline followed 0.5 gram is requested in the case of solids and semisolids) mixed with an appropriate solvent
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- 0.5 g of the test substance diluted in an appropriate solvent is spread on a gauze patch, measuring 2,5 x 2,5 cm which is applied on the abraded and intact skin of 6 albino rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed and reactions are recorded. Readings are made again 72 hours after application.
(Abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed in any animal at any timepoint.
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
- Executive summary:
Test material was subject to an acute dermal irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g of the test substance dissolved in an appropriate solvent for 24 h under occlusive conditions and the skin responses were recorded 24 h and 72 after application (i.e. 0 and 48h after patch removal). No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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