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EC number: 279-015-1 | CAS number: 78952-61-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17. March to 17 April 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 84/449/EWG, B.6 (Magnusson-Kligman-Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
Test material
- Reference substance name:
- 5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- EC Number:
- 279-015-1
- EC Name:
- 5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
- Cas Number:
- 78952-61-1
- Molecular formula:
- C27H22ClN7O16S5.xNa
- IUPAC Name:
- sodium 5-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Red 198
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 267 to 315 g
- Housing: 5/cage
- Diet: Altromin 3112 guinea pig maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17. March to 17 April 1992
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% / 0.1 mL per injection
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25 % / 0.5 mL
- Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Determination of primary non-irritating concentration: 6
Determination of the intradermal tolerance: 3
Number of animals in attending group: 5
Number of animals in test group: 10 Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
- Determination of primary non-irritating concentration: dermal-occlusive exposure for 24 hours - 3 concentrations (25%, 5%, 1%)
- Determination of the intradermal tolerance: intradermal injection: 2 x 3 concentrations (5%, 1%, 0.2%)
MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, 5% TS in 0.9% NaCl, 5% TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 8
- Site: shoulder
B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 25%
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: TS + water
- Control group: TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- In addition to the control group, 5 further guinea pigs (attending group) were used to confirm that challenge exposure with 25% TS would not lead to dermal irritation in animals pre-treated with 50% FCA.
- Positive control substance(s):
- yes
- Remarks:
- bi-annual validation of assay
Results and discussion
- Positive control results:
- valid
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin slightly reddish stained by TS
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- skin slightly reddish stained by TS
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- skin slightly reddish stained by TS
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- skin slightly reddish stained by TS
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no evidence of a positive reaction in animals after challenge treatment with Reactive Red 198 in the present study.
According to the classification criteria of Directive 83/467/EEC, Reactive Red 198 is not sensitizing in the guinea pig maximization test and therefore not subject to labelling requirements. - Executive summary:
Testing for sensitizing properties of Remazol-Rot RB FW getr. was performed in female Guinea pigs according to the method of MAGNUSSON &KLIGMAN.
Intradermal induction was performed using 5% Remazol-Rot RB FW getr. in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Rot RB FW getr. in isotonic saline.
Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study there is no evidence for sensitizing properties of Remazol-Rot RB FW getr.
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