Registration Dossier
Registration Dossier
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EC number: 277-616-3 | CAS number: 73816-74-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8.3.-22.4.1994
- 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:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in year 1994.
Test material
- Reference substance name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- EC Number:
- 277-616-3
- EC Name:
- Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Cas Number:
- 73816-74-7
- Molecular formula:
- C28H24ClN7O10S3.3Na
- IUPAC Name:
- trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Red 45:1
- Physical state: red solid powder
- Analytical purity: 85% (w/w)
- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 15% (w/w)
- Lot/batch No.: 7010
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Anlab s.r.o., Praha
- animals: healthy young adult males, nulliparous, non-pregnant
- Weight at study initiation: 300g-336g
- Housing: plastic cages, 5 animals in each cage
- Diet: ad libitum,
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C permanently monitored huminidy
- Humidity (%): 50%±15% permanently monitored huminidy
- Photoperiod: 12 light/12 dark, fluorescent lighting
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua pro injection, vaselinum alba
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua pro injection, vaselinum alba
- No. of animals per dose:
- No.of animals per sex per dose: 10 control + 20 exposed animals
- Details on study design:
- Exposed group
- day 0 - intradermal injections : injections 2 x 0.1 mL in the shoulder region, 20 exposed animals
1 – a 1:1 mixture (v/v) Freunds Complete Adjuvant FCA/aqua pro iniectione
2 - 1% solution of test sample in aqua pro iniectione
3 - 1% solution of test sample in injection 1 (1:1)
Control group
1 – a 1:1 mixture (v/v) Freunds Complete Adjuvant FCA/aqua pro iniectione
2 - aqua pro iniectione
3 - aqua pro inietione in injection 1 (1:1)
– day 7 - topical application
– exposed group - 25% sample in vaselinum alba on filter paper – applied to the test area and held in contact by an occlusive dressing (for 48 hours)
-control group – filter paper with vaselinum alba
- with occluded patch (sample in vaseline) - Challenge controls:
- Challenge: day 20 – control and exposed group
-concertation: 1% test substance in aqua pro injectione - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no pathological reaction of skin
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: not included
- Group:
- positive control
- Dose level:
- not included
- Remarks on result:
- other: Not included
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non-sensitizer in all animals no erythema and no oedema were recorded
- Executive summary:
The test substance Reactive Red 45:1 was tested for the assessment of skin allergic effects using albino guinea pigs.
The method is analogous to the OECD Test Guideline No. 406, Skin sensitisation.
The Magnusson and Kligman maximization procedure was followed.
The main test was performed on 20 treated and 10 control animals.
The experiment proceeded in three phases: two induction phases - topical application and the challenge phase. Potential skin reactions were evaluated at the end of experiment.
The evaluation of skin reactions in the exposed group carried out at 48 and 72 hours after the start of the challenge phase of study did not show any changes in skin of animals in both flanks.
No allergic skin reactions were observed incontrol group 48 hours and at 72 hoursfrom the start of application of the challenge dose.
No other negative clinical symptoms through the experiment were recorded.
The test substance Reactive Red 45:1, was not shown to be a contact allergen in guinea pigs.
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