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Registration Dossier
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EC number: 218-524-5 | CAS number: 2172-33-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study completion date: 29 February, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- EC Number:
- 218-524-5
- EC Name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- Cas Number:
- 2172-33-0
- Molecular formula:
- C42H18N2O6
- IUPAC Name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- Test material form:
- not specified
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Code No. : FAT 46014/F
Batch No. : EN 94071.32
Stability: guaranteed by the sponsor until November 1988
Description: solid
Contents of active ingredient: 35.7 %
Test Article Received: December 6, 1983
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1930-2270 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 cm²
SCORING SYSTEM:
<0.5: non-irritant
0.6 - 3.0: slightly irritant
3.1 - 5.0: irritant
5.1 - 8.0: severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Animal #3 had slight erythema at 1 hour observation only
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Animal #3 has slight edema at 1 hour observation only.
- Irritant / corrosive response data:
- None
- Other effects:
- None
Any other information on results incl. tables
Scoring of erythema and eschar formation.
| Animal No./Sex | 1h | 24h | 48h | 72h | days | days |
| 34/F | 0 | 0 | 0 | 0 | ||
| 35/F | 0 | 0 | 0 | 0 | ||
| 36/F | 1 | 0 | 0 | 0 | ||
| Total | 1 | 0 | 0 | 0 | = 1 | (A) |
Scoring of Oedema formation
| Animal No./Sex | 1h | 24h | 48h | 72h | days | days |
| 34/F | 0 | 0 | 0 | 0 | ||
| 35/F | 0 | 0 | 0 | 0 | ||
| 36/F | 1 | 0 | 0 | 0 | ||
| Total | 1 | 0 | 0 | 0 | = 1 | (B) |
Index of Skin irritation: A1 + B1 = 2 :12 = 0.17
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 46014/F was found to be non-irritant and not corrosive when applied to the rabbit skin.
- Executive summary:
The skin irritation potential of FAT 46014/F with purity of 35.7 % was evaluated in a study conducted according to OECD Guideline 404. 3 Female rabbits were used for this purpose. This test was conducted in GLP compliance. The test was carried out on shaved intact skin. Animal #3 had slight erythema and edema at 1 hour observation only, which was resolved within 24 hours. The means scores for 24/48/72 hour observations were 0 for both erythema and edema reactions. Hence, FAT 46014/F can be classified as non-irritant and not corrosive to rabbit skin.
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