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EC number: 223-445-4 | CAS number: 3896-11-5
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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
- Justification for non-LLNA method:
- When the GPMT was performed, the LLNA did not yet exist as an OECD guideline.
Test material
- Reference substance name:
- Bumetrizole
- EC Number:
- 223-445-4
- EC Name:
- Bumetrizole
- Cas Number:
- 3896-11-5
- Molecular formula:
- C17 H18 Cl N3 O
- IUPAC Name:
- 2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 10048
- Analytical purity: 100.1 %
- Lot/batch No.: EN 325964.12
- Expiration date of the lot/batch: June, 1996
- Storage condition of test material: Room temperature
- Physical state: solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Ltd, Animal Production, 4332 Stein, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 352 - 409 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: NAFAG No. 845 (Gossau AG); ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal injections: Oleum arachidis and saline; epidermal applications: vaseline
- Concentration / amount:
- Intradermal injection: 0.1 mL of a 5% mixture of test substance in Oleum arachidis
Epidermal: 0.4 g of a 30% mixture of the test substance in vaseline
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal injections: Oleum arachidis and saline; epidermal applications: vaseline
- Concentration / amount:
- Epidermal: 0.2 g of a 20% mixture of the test substance in vaseline
- No. of animals per dose:
- 10 animals/sex/dose
- Details on study design:
- PRE-TEST:
- The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability. The following concentration of test article have been prepared for intradermal injection: 1 and 5% in oleum arachidis. Since 5% was well tolerated, this concentration was used for intradermal induction.
- The concentrations for epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations have been examined on separate animals for the determination for the maximum subirritant concentration: 1, 5, 10 and 30% in vaseline. The tested concentrations did not induce erythema reactions. 30% were chosen for epidermal induction and 20% for epidermal challenge application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous), one week between intradermal und epidermal exposure
- Exposure period: 48 h for epicutaneous
- Test groups: 1). FCA/saline 1:1 mixture, 2). test substance in Oleum arachidis, 3). test substance in FCA/saline mixture
- Control group: same as the test group with the exception that the test substance was ommited
- Site: neck
- Frequency of applications: single
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 29 (2 weeks after epidermal induction)
- Exposure period: 24 h
- Test groups: Test substance in vaseline and vaseline alone
- Control group: Vaseline and test substance on separate flanks
- Site: flank
- Evaluation (hr after end of challenge exposures): 24 and 48
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the strain is checked every 6 months with at least one of the following known sensitiser: 2,4-dinitrochlorobenzene, paraphenylene diamine or potassium dichromate.
Results and discussion
- Positive control results:
- Positive control test performed using 1-chlor-2,4-dinitrobenzol between June 17, 1991 and July 18, 1991. In the test group, test article treated animals showed 10/10 animals with positive responses at 24 and 48 hours after challenge. Vehicle control animals showed 0/10 animals with positive responses at 24 and 48 hours after challenge. In the negative control group, there were 0/10 animals with positive responses at 24 and 48 hours after challenge in both the vehicle control and test article treated animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
Mean body weights (g) |
Control |
Test group |
Control |
Test group |
Males |
Females |
|||
Day 0 |
390 |
386 |
381 |
376 |
End of study |
596 |
605 |
577 |
553 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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