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EC number: 228-412-8 | CAS number: 6262-07-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.03. – 02.08.1994
- 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)
- Version / remarks:
- OECD, Paris, 1981, Adopted 17.7.1992
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available in that period.
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate
- EC Number:
- 228-412-8
- EC Name:
- Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate
- Cas Number:
- 6262-07-3
- Molecular formula:
- C32H23N5O7S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Other name: Midlonová čerň VLCompany No. of sample 16/94Stored in the laboratory at room temperature before and during the experiment.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Charles River Co.; distribution Anlab s.r.o. Praha- Females (if applicable) nulliparous and non-pregnant: yes- Microbiological status of animals, when known: delivered with veterinary attest – no parazites, pathogen microorganisms, viruses or mold. Regular cleaning and disinfection of menagerie was done to prevent contamination by pathogens in accordance with standard operating procedures.- Age at study initiation: not specified- Weight at study initiation: 326 – 398 g- Housing: 5 animals in 1 plastic cage T4 type- Diet (e.g. ad libitum): standard granulated mixture TM- Water (e.g. ad libitum): water acc. to ČSN 757111 with addition of ascorbic acid (20 mg/animal/day)- Acclimation period: 1 week as minimum- Indication of any skin lesions: good health status was confirmed by clinical observation at delivery timeENVIRONMENTAL CONDITIONSAutomatically controlled ventilation, temperature, humidity and lighting - no detailed specifications- Photoperiod (hrs dark / hrs light): 12 /12
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 2
- Details on study design:
- RANGE FINDING TESTS: Test primary irritation Filter paper slices saturated with Midlonová čerň VL in various concentrations were fixed on animal flank in occluding dressing for 24 hours. One hour after removing the bandage, the sample was evaluated for local irritation. It was found that 3% solution of testing substance in water is completely non-irritating to the skinMAIN STUDYA. INDUCTION EXPOSUREInduction intradermal exposure- No. of exposures: 3x2 injection with 0.1 ml- Test groups: 20 females Injection No. 1Freund complete adjuvans in aqua pro iniectione 1:1Injection No. 21% of Midlonová čerň VL in aqua pro iniectioneInjection No. 31% of Midlonová čerň VL in Freund complete adjuvans in aqua pro iniectione 1:1 - Control group: 10 femalesInjection No. 1Freund complete adjuvans in aqua pro iniectione 1:1Injection No. 2aqua pro iniectioneInjection No. 350% aqua pro iniectione and 50% Freund complete adjuvans in aqua pro iniectione 1:1Induction epicutaneous exposureTest group 7. dayFilter paper slice (2x4cm) coated with 25% of Midlonová čerň VL in vaselinum album was applied to an area identical with the site of intradermal injections and fixed by occlusive coverage for 48 hours.Control group 7. day as test group, but with vaselinum album only.- Exposure period: 48 hours- Site: nape - Frequency of applications: - Duration: - Concentrations: 25% of Midlonová čerň VL in vaselinum albumB. CHALLENGE EXPOSUREFilter paper slice (2x2cm) saturated with Midlonová čerň VL in 3% concentration in aqua for iniectione was fixed on animal flank in occluding dressing for 24 hours. One hour after removing the bandage and rinsing with water, the sample was evaluated for erythema/edema intensity after 1, 24, 48 and 72 hours. - No. of exposures: 2 - Day(s) of challenge: 20th, 27th - Exposure period: 24 hours - Test groups: 20 females - Control group: 10 females - Site: flank - Concentrations: 3% concentration of test substance in aqua for iniectione - Evaluation (hr after challenge): 1, 24, 48, 72 hours
- Challenge controls:
- 10 females
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 3% concentration of test substance in aqua for iniectione
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive dermal reaction was found in testing and control groups after challenge exposures.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% concentration of test substance in aqua for iniectione
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive dermal reaction was found in testing and control groups after challenge exposures.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% concentration of test substance in aqua for iniectione
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive dermal reaction was found in testing and control groups after challenge exposures.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3% concentration of test substance in aqua for iniectione
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No positive dermal reaction was found in testing and control groups after challenge exposures.
Any other information on results incl. tables
EVALUATION OF RESULTS
The evaluation uses values 24 hours after patch removal, when the irritation caused by a bandage disappears and the reaction of the test is clear. A positive result is expressed by erythema, edema, signs of bald spots in the fur on place of the patch test.
There were no positive skin reactions at the first or after repeated induction of a hypersensitivity response. There were not differences in the growth and development of animals between experimental and control groups.
classification according to Magnusson-Klingman
classification | % sensitized animals |
I. weak | 0 – 8% |
II. moderate | 9 – 28% |
III. medium | 29 – 64% |
IV. strong | 65 – 80% |
V. extreme | 81 – 100% |
Number of animals sensitized determines the potency of the contact allergen. When more than 10% there is usually a risk that the sensitization occurs in man.
Midlonová čerň VL is not sensitiser for guinea pigs. None of 20 animals from tested group responded with hypersensitivity.
Criteria according to references:
Wahlberg J.E., Boman A.: Guinea pig Maximization Test. In: Contact Alergy. Predictive tests In Guinea Pigs. Editors: Andersen K.E., Maibach H.I. 1985, Karger, 59 - 106
Janečková V., Znojemská S.: Kontaktní senzibilizace. Acta Hygienica epidemiologica et microbiologica. 2/1992, 1-5.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No positive dermal reaction was found in testing and control groups after challenge exposures.
- Executive summary:
EVALUATION OF RESULTS
The evaluation uses values 24 hours after patch removal, when the irritation caused by a bandage disappears and the reaction of the test is clear. A positive result is expressed by erythema, edema, signs of bald spots in the fur on place of the patch test. There were no positive skin reactions at the first or after repeated induction of a hypersensitivity response. There were not differences in the growth and development of animals between experimental and control groups.
Midlonová čerň VL is not sensitiser for guinea pigs. None of 20 animals from tested group responded with hypersensitivity.
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