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EC number: 413-210-6 | CAS number: 192662-33-2 ORASOL ROT 1988C
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD testing guideline compliant study with well characterized test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
- EC Number:
- 413-210-6
- EC Name:
- tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate
- Cas Number:
- 192662-33-2
- Molecular formula:
- UVCB substance
- IUPAC Name:
- chromium(3+) 2-methyltridecan-2-aminium bis(4-{2-[5-(2,2-dimethylpropyl)-3-nitro-2-oxidophenyl]diazen-1-yl}-3-methyl-1-(3-sulfamoylphenyl)-1H-pyrazol-5-olate)
- Details on test material:
- - Substance type: pigment, powder
- Physical state: solid
- Purity test date: no data
- Lot/batch No.: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997
- Stability under test conditions: yes
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein, Switzerland
- Age at study initiation:
- Weight at study initiation: 321 to 408 g.
- Housing: 1 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-12-14 To: 1993-01-14
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 20 % Propylen-glycol for intradermal injection and vaseline for epicutaneous application
- Concentration / amount:
- Intradermal injections:
- 5% in 20 % propylene glycol (w/v)
- 5% in the adjuvant/saline mixture (w/v)
Epidermal applications
50% in vaseline (induction)
20% (challenge) (30% and 50% in vaseline caused erythema in the range-finder study)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 20 % Propylen-glycol for intradermal injection and vaseline for epicutaneous application
- Concentration / amount:
- Intradermal injections:
- 5% in 20 % propylene glycol (w/v)
- 5% in the adjuvant/saline mixture (w/v)
Epidermal applications
50% in vaseline (induction)
20% (challenge) (30% and 50% in vaseline caused erythema in the range-finder study)
- No. of animals per dose:
- 20 (test item)
10 (control) - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48h (epidermal eposure)
- Test groups: yes
- Control group: yes
- Site: neck
- Frequency of applications: once per week
- Duration: 4 weeks
- Concentrations: see above
During weeks 3 and 4 no treatments were performed.
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 1
- Exposure period: 24h
- Test groups: yes
- Control group: yes
- Site: flank
- Concentrations: 20%
- Evaluation (hr after challenge): 24 and 48h
OTHER:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea
pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in 20 % propylene glycol in water (w/v)
- test article in the adjuvant/saline mixture (w/v) - Challenge controls:
- vehicle (vaseline)
- Positive control substance(s):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
- Positive control results:
- A sensitization rate of 90% was observed in the experimental animals after the challenge with 1% (w/w) potassium dichromate in vaseline.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% . No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 19.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
On experimental day 17 female guinea pig No. 53 was found dead. Macro pathological investigation did not reveal any changes. Since no clinical signs were observed in all other treated guinea pigs and with respect to the low incidence of this finding, no toxicological
relevance is attributed to this death.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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