Registration Dossier
Registration Dossier
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EC number: 400-640-4 | CAS number: 198153-89-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Sep - 13 Oct 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
EEC Directive 79/831
- Principles of method if other than guideline:
- The test was carried out according to the maximization test of Magnusson and Kligman (J. invst. Dermatol. 52, 268-276, 1969), recommended in the OECD guidelines 1981 and in the EEC directive 79/831.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study predates availability of the LLNA method.
Test material
- Reference substance name:
- -
- EC Number:
- 400-640-4
- EC Name:
- -
- Cas Number:
- 198153-89-8
- Molecular formula:
- C32ClH25N10Na2O9S3
- IUPAC Name:
- disodium 2-(4-{[4-({3-[2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]-4-sulfonatophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}phenyl)-6-methyl-1,3-benzothiazole-7-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 161
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy, Basel, Switzerland
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: ca. 10 wks
- Weight at study initiation: 309 - 459 g
- Housing: Macrolon Type III cage, individual housing
- Diet (e.g. ad libitum): standard guinea pig pellets, NAFAG No. 84 6, Gossau SG, ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: n/a
- Indication of any skin lesions: healthy
- Sensitivity controlled every six months with p-phenylenediamine
- Acclimatisation: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 60 % rh
- Photoperiod (hrs dark / hrs light): 14 / 10
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- and Freud adjuvant
- Concentration / amount:
- 1% / 0.1 mL
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% / 0.4 g
- Day(s)/duration:
- 48 h occlusive, then 12 days until challenge
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 30% / 0.2 g
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Details on study design:
- The concentrations of the test compound for induction and challenge periods were determined on separate animals.
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as .with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- p-phenylenediamine
Results and discussion
- Positive control results:
- Not reported. Guinea pigs are tested every 6 months for sensitivity.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not induce any effects of skin sensitisation in an in vivo study with guinea pigs (OECD 406, maximisation test).
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