Registration Dossier
Registration Dossier
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EC number: 260-906-9 | CAS number: 57693-14-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A reliable GPMT was available.
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 260-906-9
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Cas Number:
- 57693-14-8
- Molecular formula:
- C40H20CrN6O14S2.3Na
- IUPAC Name:
- trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRl, Biological Research laboratories ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 336 - 391 9
- Housing: single
- Diet: ad lib.
- Water: ad lib.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 52 - 74
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal: 5 %
epidermal induction: 25 %
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 %
- Day(s)/duration:
- day 22
- No. of animals per dose:
- Control: 5
Treated: 10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epidermal
- Exposure period: 8 days
- Test groups: 10 animals
- Control group: 5 animals
- Site: scapular area
- Frequency of applications: 2 at a weeks distance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Site: flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- Opposite flank
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- positive indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: no data
Any other information on results incl. tables
Test group skin response after challenge (25 % test substance in distilled water) after 24 and 48 h
| animal | sex | erythema | edema | erythema | edema |
| 11 | male | 1 | 0 | 1 | 0 |
| 12 | male | 1 | 0 | 1 | 0 |
| 13 | male | 2 | 0 | 3 | 0 |
| 14 | male | 2 | 0 | 2 | 0 |
| 15 | male | 3 | 0 | 2 | 0 |
| 16 | male | 1 | 0 | 2 | 0 |
| 17 | male | 2 | 0 | 2 | 0 |
| 18 | male | 2 | 0 | 3 | 0 |
| 19 | male | 2 | 0 | 1 | 0 |
| 20 | male | 1 | 0 | 1 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: skin sensitising according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The test item cause skin reactions after challenge in all treated animals.
- Executive summary:
Method
The allergenic potential of test substance was assessed in albino guinea pigs by the maximization-test of B. Magnusson and A.M. Kligman (1969), as per OECD guideline 406 .
Five males were used as control group and 10 males were used as test group.
The highest non-irritating test article concentration used for challenge application was 25% in bi-distilled water.
Results
All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure; no reactions were seen in the negative control group.
Test material is judged skin sensitising.
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