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EC number: 606-251-8 | CAS number: 1917-44-8
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Feb - 16 Apr 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
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)
- Version / remarks:
- (adopted 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-Hydroxy-4,6-diphenyl-1,3,5-triazin
- IUPAC Name:
- 2-Hydroxy-4,6-diphenyl-1,3,5-triazin
- Details on test material:
- Test article: FAT 92376/A
Additional specification: 2-Hydroxy-4,6-diphenyl-1,3,5-triazin
Batch No: 10.26
Analytical purity: 98%
Physical properties: white crystals
Storage conditions: room temperature
Constituent 1
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: Pirbright White Strain (Tif: DHP) guinea pigs from CIBA-GEIGY Limited, Animal Production, 4332 Stein/Switzerland
- Age at study initiation: no data
- Weight at study initiation: 326 - 403 g
- Housing: single housing in Makrolon Type 3 cages
- Diet: standard guinea pig pellets (NAFAG No. 845, Gossau SG), ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- Induction:
Intradermal:
5% FAT 92376/A in Oleum arachidis (w/v)
5% FAT 92376/A in the adjuvant/saline mixture (w/v)
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.4 g per patch
Challenge:
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.2 g per patch
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- Induction:
Intradermal:
5% FAT 92376/A in Oleum arachidis (w/v)
5% FAT 92376/A in the adjuvant/saline mixture (w/v)
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.4 g per patch
Challenge:
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.2 g per patch
- No. of animals per dose:
- Control: 5 animals per sex
Dose groups: 10 animals per sex - Details on study design:
- RANGE FINDING TESTS:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 92376/A have been examined on separate animals for the determination of the maximum subirritant concentration: 80% in vaseline was the highest applicable concentration of the test article. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% (w/w) was chosen.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous, occlusive)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: Oleum arachidis
Injection 3: a 1:1 mixture (v/v) FCA/water
Epicutaneous: 50% in vaseline
- Tests groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in Oleum arachidis (w/v)
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: 50% in vaseline
- Site: into the neck region
- Frequency of applications: Every 7 days
- Duration: Days 0-9
- Concentrations:
Intradermal:
Test group: 5%
Epicutaneous:
Test group: 50% in vaseline (0.4 g paste per patch)
B. CHALLENGE EXPOSURE
- No. of exposures: 1(epicutaneous, occlusive)
- Day of challenge: 4 weeks after first induction
- Exposure period: 24 h
- Test groups:
Epicutaneous: 50% in vaseline
- Control group:
Epicutaneous: 50% in vaseline and vaseline alone
- Site: on the flank
- Concentrations: 0 and 50%
- Evaluation (hr after challenge): 24 and 48 h
OTHER:
The application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- potassium dichromate
Results and discussion
- Positive control results:
- No positive controls were included in this study. The reference values with potassiumdichromate were reported (experimental date Nov-Dec 1992).
Potassiumdichromate (Intradermal induction: Concentration of compound: 0-2%; Vehicle: physiological saline; Epidermal induction: Concentration of compound: 5%; Vehicle: vaseline; Epidermal challenge: Concentration of compound: 1%; Vehicle: vaseline) induced reactions in 9/10 animals, thus meeting the reliability criteria (>= 15% positive responders).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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