Registration Dossier
Registration Dossier
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EC number: 218-524-5 | CAS number: 2172-33-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Buehler test has been selected, because it is one of the recommended tests in the OECD guideline 406, adopted May 12,1981, adapted July 17,1992, as well as in Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
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:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Identification: FAT 46014/G, Solid yellow powder
- Lot/batch number of test material: 258645.16
- Purity: 99.8%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions of test material: Room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 283 to 359 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation date: September 22, 1993
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours ligh-cycle day
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Distilled
- Concentration / amount:
- 30%
- Day(s)/duration:
- Week 1 to 3
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 5%
- Day(s)/duration:
- Week 5
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- - 10 male and 10 female guinea pigs in test group.
- 5 males and 5 females in the control group. - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three epidermal occlusive test article applications on the same skin site for 6 hours each (weeks 1 t o 3)
- Exposure period: 3 weeks
- Test groups: Epidermal induction (weeks 1 to 3)
- Control group: Distilled water
- Site: Epidermal
- Frequency of applications: Once a week
- Duration: 6 hours
- Concentrations: 30 % in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Exposure period: 6 hours
- Control group: Distilled water
- Site: Epidermal
- Concentrations: 5 % in distilled water
- Evaluation (hr after challenge): Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to a modified Draize scoring scale.
This test consists of an induction period with three epidermal occlusive test article applications on the same skin site for 6 hours each (weeks 1 t o 3), a rest period of 13 to 15 days, followed by a challenge period with epidermal occlusive application of the test article for 6 hours (week 5 ).
For all epidermal applications in the test and control group the following self-adhesive and occlusive chamber was used:
Hill Top Chamber"11 full system: 25 mm (Hill Top Research, Inc., Cincinnati , USA)
Approximate volume applied: 0.35 ml/chamber ( fully loaded)
Control group
The control group was treated with the vehicle during the induction period . Like in the test group the maximum sub-irritant concentration of FAT 46014/G was tested during challenge in these animals. - Challenge controls:
- Distilled water
- Positive control substance(s):
- yes
- Remarks:
- potassium-dichromate
Results and discussion
- Positive control results:
- After 24 hrs: 11/19 animals showed a positive result.
After 48 hrs: 9/19 animals showed a positive result.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05 %
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 9
- Total no. in group:
- 19
Any other information on results incl. tables
One of the male animal was found dead on experimental day 3. Macropathological investigations of this animal showed an ulcer, perforating the small intestine.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 46014/G is classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
- Executive summary:
A key study was conducted to determine the skin sensitisation potential of FAT 46014/G (purity: 99.8 %) in guinea pigs. Test was carried out in GLP compliance and followed the OECD guideline 406. Under the experimental conditions employed, 58 and 47 % of the 19 animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. FAT 46014/G is therefore, classified as a sensitiser in albino guinea pigs according to the EEC Classification criteria (Commission Directive 93/21/EEC, April 27, 1993).
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